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    Summary
    EudraCT Number:2021-003993-30
    Sponsor's Protocol Code Number:IDP-121-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-003993-30
    A.3Full title of the trial
    A phase 1/2 multicenter, open-label, dose-escalation study of IDP-121 in patients with relapsed/refractory hematologic malignancies
    Estudio fase 1/2 multicéntrico, abierto, de escalado de dosis de IDP-121 en pacientes con neoplasias hematológicas en recaída/refractarias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of IDP-121 in patients with relapsed/refractory hematologic malignancies
    Estudio de IDP-121 en pacientes con neoplasias hematológicas en recaída/refractarias
    A.4.1Sponsor's protocol code numberIDP-121-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIDP Discovery Pharma S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIDP Discovery Pharma S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science, S.L.U
    B.5.2Functional name of contact pointDepartamento de operaciones
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda Josep Tarradelles, 8-10, 5º4ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933511615
    B.5.5Fax number0034933496341
    B.5.6E-mailensayosclinicos@dynasolutions.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIDP121
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeIDP-121
    D.3.9.3Other descriptive nameIDP-121
    D.3.9.4EV Substance CodeSUB235791
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic lymphocytic leukemia (CLL)
    Diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS)
    High-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH)
    High-grade B cell lymphoma not otherwise specified (HGBL-NOS)
    Multiple myeloma (MM)
    Leucemia linfocítica crónica (CLL)
    Linfoma difuso de células B grandes sin otra especificación (DLBCL-NOS)
    Linfoma de células B de alto grado con reordenamiento de doble o triple hit (HGBL-DH/TH)
    Linfoma de células B de alto grado sin otra especificación (HGBL-NOS)
    Mieloma múltiple (MM)
    E.1.1.1Medical condition in easily understood language
    Chronic lymphocytic leukemia, some types of lymphoma and multiple mieloma.
    Leucemia linfocítica crónica, algunos tipos de linfoma y mieloma múltiple.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10020068
    E.1.2Term High grade B-cell lymphomas Burkitt-like lymphoma
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012820
    E.1.2Term Diffuse large B-cell lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020069
    E.1.2Term High grade B-cell lymphoma Burkitt-like lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL).
    Phase II: To evaluate the overall response rate (ORR) in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
    Fase I: Determinar la dosis máxima tolerada (DMT) y la dosis recomendada para la fase 2 (DRF2) de IDP-121 en pacientes con mieloma múltiple (MM), linfoma difuso de células B grandes no especificado (DLBCL-NOS), linfoma de células B de alto grado con reordenamiento doble/triple hit (HGBL-DH/TH), linfoma de células B de alto grado no especificado (HGBL-NOS), y leucemia linfocítica crónica (LLC).
    Fase II: Evaluar la tasa de respuesta global (TRG) en pacientes con MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS y LLC tratados con IDP-121 en la dosis recomendada para la fase 2 (DRF2).
    E.2.2Secondary objectives of the trial
    • To determine additional efficacy objectives, including duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at the RP2D.
    • To evaluate the safety of IDP-121 at the RP2D.
    • To determine the pharmacokinetic (PK) profile of IDP-121 in patients with CLL, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS and MM.
    • To determine the cMyc levels before and during the treatment.
    • To explore pharmacodynamics (PD) parameters of the activity of IDP-121.
    • To explore/evaluate predictive biomarkers of anti-tumor efficacy of IDP-121 and/or for patient selection for future clinical evaluation.
    • Determinar otros objetivos de eficacia, como duración de la respuesta (DR), tiempo hasta la progresión (TP), supervivencia libre progresión (SLP), supervivencia libre de eventos (SLE) y supervivencia global (SG) con la DRF2.
    • Evaluar la seguridad de IDP-121 en la DRF2.
    • Determinar el perfil farmacocinético (FC) de IDP-121 en pacientes con LLC, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS y MM.
    • Determinar los niveles de cMyc antes y durante el tratamiento.
    • Explorar parámetros farmacodinámicos (FD) de la actividad de IDP-121.
    • Explorar/evaluar biomarcadores predictivos de la eficacia antitumoral de IDP-121 y/o para la selección de pacientes para futuras evaluaciones clínicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Performance status (ECOG) < 2
    3. Life expectancy ≥ 3 months
    4. Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.
    5. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    6. Patients diagnosed with chronic lymphocytic leukemia (CLL), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH), HGBL-NOS and multiple myeloma (MM) who are ineligible to receive the available treatments.
    7. Adequate hematological or biochemical parameters as specified below
    a. Hemoglobin > 8.0 g/dl (without transfusion support within 7 days)
    b. Platelets count > 75 x109/L (without transfusional support within 7 days)
    c. Absolute neutrophil count (ANC) > 0.75 x109/L (without G-CSF support within 7 days)
    d. Aspartate transaminase (AST): <2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases)
    e. Alanine transaminase (ALT): < 2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases)
    f. Total bilirubin: < 2 x the upper limit range.
    g. Calculated or measured creatinine clearance: > 50 mL/min (calculated from the Cockcroft-Gault formula).
    8. Left ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower .
    1. Edad ≥18 años.
    2. Estado funcional (ECOG) <2.
    3. Esperanza de vida ≥ 3 meses.
    4. En opinión del investigador, el paciente está dispuesto y es capaz de cumplir con los requisitos del protocolo
    5. El paciente ha otorgado su consentimiento informado voluntario por escrito antes de la realización de cualquier procedimiento del estudio que no forme parte de la atención médica habitual, entendiéndose que el paciente podrá retirar su consentimiento en cualquier momento sin perjuicio alguno para la asistencia médica que reciba en el futuro.
    6. Pacientes diagnosticados de leucemia linfocítica crónica (LLC), linfoma difuso de células B grandes no especificado (DLBCL-NOS), linfoma de células B de alto grado con reordenamiento doble/triple hit (HGBL-DH/TH), linfoma de células B de alto grado no especificado (HGBL-NOS) y mieloma múltiple (MM) que no sean aptos para los tratamientos disponibles.
    7. Parámetros hematológicos o bioquímicos adecuados según se especifica a continuación:
    a. Hemoglobina >8,0 g/dl (sin soporte transfusional en 7 días).
    b. Recuento de plaquetas >75 x 109/l (sin soporte transfusional en 7 días).
    c. Recuento absoluto de neutrófilos (RAN) >0,75 x 109/l (sin soporte con G-CSF en 7 días).
    d. Aspartato transaminasa (AST): <2,5 veces el límite superior de normalidad (LSN) en pacientes sin metástasis hepáticas o <5 veces el LSN en pacientes con metástasis hepáticas).
    e. Alanina transaminasa (ALT): <2,5 veces el límite superior de normalidad (LSN) en pacientes sin metástasis hepáticas o <5 veces el LSN en pacientes con metástasis hepáticas).
    f. Bilirrubina total: <2 veces el límite superior de normalidad
    g. Aclaramiento de creatinina calculado o medido: >50 ml/min (calculado con la fórmula de Cockcroft-Gault).
    8. Fracción de eyección del ventrículo izquierdo >50 % o por encima del límite inferior de normalidad (LIN) del centro, el que sea más bajo.
    E.4Principal exclusion criteria
    1. Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.
    2. Pregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence).
    *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    3. History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).
    4. History of clinically significant hypotension.
    5. History of clinically significant allergic or hyper-sensitivity reactions.
    6. History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):
    - Thromboembolism
    - Peripheral arterial disease
    - Vasculitis
    7. Other relevant diseases or adverse clinical conditions:
    - Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
    - Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).
    - History of significant neurological or psychiatric disorders
    8. Clinically significant or active infection.
    9. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
    10. The patient is known to be human immunodeficiency virus (HIV) positive, Hepatitis B surface antigen-positive, active hepatitis C infection or CMV positive.
    11. Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.
    12. Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunossupresive treatment
    13. Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
    14. If a COVID-19 vaccine is administered it should be done >72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase”).
    1. Toxicidad no hematológica clínicamente significativa persistente relacionada con los tratamientos previos. Se permite la presencia de alopecia y neuropatía periférica sintomática de grado <2 según los CTCAE del NCI.
    2. Mujeres embarazadas o en periodo de lactancia; varones y mujeres en edad fértil* (como define el Anexo 2) que no utilicen métodos anticonceptivos altamente eficaces (anticoncepción hormonal combinada asociada a la inhibición de la ovulación; anticoncepción hormonal sólo de progestágenos asociada a la inhibición de la ovulación, dispositivo intrauterino, sistema liberador de hormonas intrauterino, oclusión tubárica bilateral, pareja vasectomizada, abstinencia sexual).
    * Una mujer se considera en edad fértil después de la menarquia y hasta la postmenopausia, a menos que sea permanentemente estéril. Un hombre se considera fértil después de la pubertad, a menos que sea permanentemente estéril por orquiectomía bilateral.
    3. Antecedentes de cualquier otra neoplasia en los últimos cinco años (excepto carcinoma de células basales, epitelioma cutáneo o carcinoma in situ de cualquier localización).
    4. Antecedentes de hipotensión clínicamente significativa.
    5. Antecedentes de reacciones alérgicas o de hipersensibilidad clínicamente significativas.
    6. Antecedentes o enfermedad vascular clínicamente significativa, o alto riesgo conocido de enfermedad vascular (según la evaluación del médico responsable del tratamiento), entre ellos:
    - Tromboembolismo
    - Enfermedad arterial periférica
    - Vasculitis.
    7. Otras enfermedades relevantes o alteraciones clínicas adversas:
    - Insuficiencia cardiaca congestiva o angina de pecho, infarto de miocardio en los 12 meses previos a la inclusión en el estudio.
    - Hipertensión arterial o arritmias cardiacas no controladas (es decir, que requirieron modificar la medicación en los últimos 3 meses o ingreso hospitalario en los últimos 6 meses).
    - Antecedentes de trastornos neurológicos o psiquiátricos importantes.
    8. Infección clínicamente significativa o activa.
    9. Enfermedad hepática no neoplásica significativa (por ejemplo, cirrosis o hepatitis crónica activa).
    10. El paciente es positivo para el virus de la inmunodeficiencia humana (VIH), positivo para el antígeno de superficie del virus de la hepatitis B, tiene infección activa por hepatitis C o es positivo para el CMV.
    11. Tratamiento antitumoral concomitante en los 14 días previos al Día 1 del Ciclo 1.
    12. Trasplante alogénico previo en los últimos 3 meses o enfermedad de injerto contra huésped (EICH) actualmente activa con tratamiento inmunosupresor.
    13. Limitación de la capacidad del paciente para cumplir el protocolo de tratamiento o de seguimiento.
    14. En caso de administrar una vacuna contra la COVID-19, deberá hacerse más de 72 horas antes del inicio del tratamiento del estudio o después de completar el periodo de evaluación de la toxicidad limitante de la dosis (TLD) (si el paciente participa en la fase de escalado de dosis).
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    1. Maximum tolerated dose (MTD): based on the incidence of DLTs observed at the end of Cycle 1 (28 days)
    2. Recommended phase 2 dose (RP2D): dose used in subsequent Expansion phase. The RP2D will be determined in discussion with the Investigators and the Sponsor based on safety (dose limiting toxicity), PK, PD and any cumulative toxicity after multiple cycles.
    Phase II:
    3. Overall response rate (ORR) for CLL, MM and Lymphomas, respectively.
    FaseI:
    1. Dosis máxima tolerada (DMT): basada en la incidencia de TLD observada al final del ciclo 1 (28 días).
    2. Dosis recomendada para la fase 2 (DRF2): dosis utilizada en la siguiente fase de expansión. La DRF2 se discutirá con los investigadores y el promotor en función de la seguridad (toxicidad limitante de la dosis), FC, FD y cualquier toxicidad acumulada después de varios ciclos.
    Fase II:
    3. Tasa de respuesta global (TRG) basada en las directrices/criterios de respuesta específicos de cada tumor
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. End of Cycle 1
    2. End of treatment
    3. End of treatment
    1. Fin del ciclo 1
    2. Fin del tratamiento
    3. Fin del tratamiento
    E.5.2Secondary end point(s)
    1. Eficacy endpoints:
    • Duration of response (DoR), defined as the time from documentation of disease response to disease progression.
    • Time to progression (TTP), time from the first treatment day to objective disease progression; does not include deaths.
    • Progression-free survival (PFS) defined as the interval between the first treatment day to the first sign of disease progression or death from any cause.
    • Event-free survival (EFS) defined as the interval time between the first treatment day to disease progression, death, or discontinuation of treatment from any cause (e.g., toxicity, patient preference, or initiation of a new treatment without documented progression).
    • Overall survival (OS) defined as the interval between the first treatment day to death from any cause.
    2. Safety endpoints: vital signs, physical examination, hematology, biochemistry, urinalysis, electrocardiograms (ECG), all grades AEs and SAEs.
    3. Pharmakocinetics Endpoints:
    • AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
    • Cmax: maximum observed plasma concentration.
    • CL: apparent total body clearance of the drug from plasma.
    • Css: steady-state plasma drug concentration during constant rate infusion.
    • Ctrough: Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]).
    • Ke: elimination rate constant.
    • t1/2: elimination half-life.
    • Tmax: time to maximum plasma concentration time.
    4. Pharmacodynamics biomarkers
    1. Criterios de valoración de la eficacia
    • Duración de la respuesta (DR), definida como el tiempo transcurrido desde la confirmación de respuesta hasta progresión de la enfermedad.
    • Tiempo hasta la progresión (TP), definido como el tiempo transcurrido desde el primer día de tratamiento hasta la progresión objetiva de la enfermedad; no incluye las muertes.
    • Supervivencia libre progresión (SLP), definida como el tiempo transcurrido desde el primer día de tratamiento hasta el primer signo de progresión de la enfermedad o muerte por cualquier causa.
    • Supervivencia libre de eventos (SLE), definida como el tiempo transcurrido desde el primer día de tratamiento hasta progresión de la enfermedad, muerte o interrupción del tratamiento por cualquier causa (por ejemplo, toxicidad, preferencia del paciente o inicio de un nuevo tratamiento sin progresión documentada).
    • Supervivencia global (SG), definida como el tiempo transcurrido desde el primer día de tratamiento hasta la muerte por cualquier causa.
    2. Criterios de valoración de la seguridad: Signos vitales, exploración física, hematología, bioquímica, análisis de orina, electrocardiograma (ECG), AA (todos los grados) y AA graves (AAG).
    3. Criterios de valoración de la farmacocinética:
    • AUClast: área bajo la curva de concentración plasmática-tiempo desde el momento 0 hasta el momento de la última concentración cuantificable.
    • Cmáx: concentración plasmática máxima observada
    • CL: aclaramiento corporal total aparente del fármaco del plasma.
    • Css: concentración plasmática del fármaco en estado estacionario durante la infusión a velocidad constante.
    • Ctrough: concentración plasmática mínima (concentración medida al final del intervalo de dosificación en estado estable [tomada directamente antes de la siguiente administración]).
    • Ke: constante de eliminación.
    • t1/2: vida media de eliminación.
    • Tmáx: tiempo en alcanzar la concentración máxima
    • Vd: volumen aparente de distribución.
    4. Biomarcadores farmacodinámicos:
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation of secondary endpoints will be done throughout the study.
    La evaluación de los criterios de valoración secundarios se realizarán durante todo el estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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