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    Summary
    EudraCT Number:2021-000138-33
    Sponsor's Protocol Code Number:R4461-PLD-20100
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-15
    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 number2021-000138-33
    A.3Full title of the trial
    A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients with Familial Partial Lipodystrophy
    Estudio aleatorizado, en doble ciego y controlado con placebo de REGN4461, un anticuerpo agonista del LEPR, en el tratamiento de las anomalías metabólicas de pacientes con lipodistrofia parcial familiar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the effects of the LEPR Agonist Antibody REGN4461 in patients with Familial Partial Lipodystrophy
    Estudio para analizar los efectos de REGN4461, un anticuerpo agonista del LEPR, en pacientes con lipodistrofia parcial familiar
    A.4.1Sponsor's protocol code numberR4461-PLD-20100
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameREGN4461
    D.3.2Product code REGN4461
    D.3.4Pharmaceutical form Lyophilisate 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 INNREGN4461
    D.3.9.1CAS number 2305770-44-7
    D.3.9.2Current sponsor codeREGN4461
    D.3.9.3Other descriptive nameREGN4461
    D.3.9.4EV Substance CodeSUB191249
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number265
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    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 nameREGN4461
    D.3.2Product code REGN4461
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN4461
    D.3.9.1CAS number 2305770-44-7
    D.3.9.2Current sponsor codeREGN4461
    D.3.9.3Other descriptive nameREGN4461
    D.3.9.4EV Substance CodeSUB191249
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number265
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Familial Partial Lipodystrophy
    Lipodistrofia Parcial Familiar
    E.1.1.1Medical condition in easily understood language
    Familial Partial Lipodystrophy
    Lipodistrofia Parcial Familiar
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10053857
    E.1.2Term Partial lipodystrophy
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives will be evaluated for patients in Cohort A only:
    • To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
    • To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline HbA1c
    Los objetivos principales se evaluarán solo en los pacientes de la cohorte A:
    • Evaluar el efecto del REGN4461 sobre los triglicéridos (TG) en ayunas en pacientes con TG en ayunas basales elevados
    • Evaluar el efecto del REGN4461 sobre la hiperglucemia en pacientes con hemoglobina A1c (HbA1c) basal elevada
    E.2.2Secondary objectives of the trial
    The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:
    • To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
    • To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia
    The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:
    • To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
    • To evaluate the effect of REGN4461 on hunger
    • To evaluate safety and tolerability of REGN4461
    • To characterize the concentration profile of REGN4461 over time
    • To assess immunogenicity to REGN4461
    Los siguientes objetivos secundarios del estudio se evaluarán en la cohorte B y en la población combinada de las cohortes A y B:
    • Evaluar el efecto del REGN4461 sobre los TG en ayunas en pacientes con hipertrigliceridemia
    • Evaluar el efecto del REGN4461 sobre el control glucémico en pacientes con hiperglucemia
    Los siguientes objetivos secundarios del estudio se evaluarán en las cohortes A y B por separado y en la población combinada de las cohortes A y B:
    • Evaluar el efecto del REGN4461 sobre la grasa hepática en pacientes con esteatosis hepática
    • Evaluar el efecto del REGN4461 sobre el apetito
    • Evaluar la seguridad y la tolerabilidad del REGN4461
    • Caracterizar el perfil de concentración del REGN4461 a lo largo del tiempo
    • Evaluar la inmunogenia del REGN4461
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Future Biomedical Research (Optional)
    Patients who agree to participate in the future biomedical research (FBR) sub-study will be required to consent to this optional sub-study before samples are banked for FBR. Additional samples will be collected for FBR.

    Pharmacogenomic Analysis (Optional)
    Patients who agree to participate in the genomics sub-study will be required to consent to this optional sub-study before collection of the samples. Whole blood samples for DNA extraction should be collected on day 1/baseline but can be collected at a later study visit.
    DNA samples will be collected for pharmacogenomics analyses to understand the genetic determinants of efficacy and safety associated with the treatments in this study and the molecular basis of PLD and related diseases.
    Investigaciones biomédicas futuras (opcional)
    A los pacientes que accedan a participar en el subestudio de investigaciones biomédicas futuras se les pedirá su consentimiento para este subestudio opcional antes de que se conserven en un banco sus muestras para investigaciones biomédicas futuras. Se obtendrán muestras adicionales para investigaciones biomédicas futuras.

    Análisis farmacogenómico (opcional)
    Se pedirá a los pacientes que accedan a participar en el subestudio genómico su consentimiento para este subestudio opcional antes de que se les obtengan las muestras. Se deberán obtener muestras de sangre entera para extracción de ADN el día 1/basal, aunque también pueden obtenerse en una visita posterior del estudio.
    Se obtendrán muestras de ADN para los análisis de farmacogenómica a fin de estudiarr los determinantes genéticos de la eficacia y la seguridad asociados con los tratamientos de este estudio y la base molecular de la LPF y enfermedades relacionadas.
    E.3Principal inclusion criteria
    1. Male or female, >/= 18 years of age at the screening visit.
    2. Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
    3. Fasting leptin level <=20ng/ml, as determined during the screening period
    4. Presence of significant metabolic abnormalities as defined in the protocol
    5. Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
    6. Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Adkins, Paleo, Vegetarianism, Veganism).
    7. No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol

    NOTE: Other protocol defined inclusion criteria apply
    1. Pacientes de ambos sexos, de >/= 18 años de edad en el momento de la visita de selección.
    2. Diagnóstico clínico de lipodistrofia parcial familiar según se define en el protocolo.
    3. Concentración de leptina en ayunas <=20 ng/ml, determinada en el periodo de selección.
    4. Presencia de alteraciones metabólicas significativas según se define en el protocolo.
    5. Peso corporal estable en los tres meses previos a la selección (sin aumentos ni pérdidas de peso de >5 % con respecto al peso actual).
    6. Dieta estable durante los tres últimos meses, definida como sin cambios importantes en la composición de macronutrientes (por ej., inicio o abandono de dietas como Atkins, Paleo, vegetarianismo, veganismo).
    7. Sin variaciones de interés clínico en la pauta de medicación en los 3 meses previos a la selección según se define en el protocolo.

    NOTA: Son de aplicación otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    1. Treatment with metreleptin within 3 months of the screening visit
    2. Patients with a diagnosis of generalized lipodystrophy
    3. Patients with a diagnosis of acquired lipodystrophy
    4. Pregnant or breastfeeding women

    NOTE: Other protocol defined exclusion criteria apply
    1. Tratamiento con metreleptina en los 3 meses previos a la visita de selección.
    2. Pacientes con diagnóstico de lipodistrofia generalizada.
    3. Pacientes con diagnóstico de lipodistrofia adquirida.
    4. Mujeres embarazadas o en período de lactancia.

    NOTA: Son de aplicación otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary:
    • Percent change in fasting serum TG from baseline to week 12 in patients with elevated baseline fasting TG and with baseline leptin <8.0 ng/mL (Cohort A)
    • Absolute change in HbA1c from baseline to week 12 in patients with elevated baseline HbA1c and with baseline leptin <8.0 ng/mL (Cohort A)
    Coprincipales:
    • Cambio porcentual de los TG séricos en ayunas desde el momento basal hasta la semana 12 en pacientes con TG en ayunas basales elevados y con leptina basal <8,0 ng/ml (cohorte A)
    • Cambio absoluto de la HbA1c desde el momento basal hasta la semana 12 en pacientes con HbA1c basal elevada y con leptina basal <8,0 ng/ml (cohorte A)
    E.5.1.1Timepoint(s) of evaluation of this end point
    As Stated Above
    Como se indicó anteriormente
    E.5.2Secondary end point(s)
    The following secondary endpoints will be analyzed for Cohort B and for the combined set of Cohorts A plus B:
    • Percent change in fasting serum TG from baseline to week 12 in patients with elevated baseline fasting TG
    • Absolute change in HbA1c from baseline to week 12 in patients with elevated baseline HbA1c
    The following secondary endpoints will be analyzed for Cohorts A and B separately, and for the combined set of Cohorts A plus B:
    • Percent change in fasting serum TG from baseline to week 12 compared to the percent change between week 12 and week 24 (study arm 1)
    • Percent change in fasting serum TG from baseline to week 24 (study arm 2)
    • Percent change in fasting serum TG after the first 12 weeks of exposure to REGN4461— from baseline to week 12 (study arm 2) and from week 12 to week 24 (study arm 1; patients must meet stability criteria)
    • Change in HbA1c from baseline to week 12 compared to the change between week 12 and week 24 (study arm 1)
    • Change in fasting glucose from baseline to week 12 compared to the change between week 12 and week 24 (study arm 1)
    • Change in HbA1c from baseline to week 24 (study arm 2)
    • Change in fasting glucose from baseline to week 24 (study arm 2)
    • Change in HbA1c from baseline to week 12 (study arm 2) and from week 12 to week 24 (study arm 1; patients must meet stability criteria)
    • Change in fasting glucose from baseline to week 12 (study arm 2) and from week 12 to week 24 (study arm 1)
    • Percent change in liver fat measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) from baseline to week 12, REGN4461 versus placebo in patients with baseline liver fat (MRI-PDFF) >/= 8.5%
    • Percent change in liver fat (MRI-PDFF) from baseline to week 12 compared to the percent change between week 12 and week 24 (study arm 1) in patients with baseline liver fat (MRI-PDFF) >/= 8.5%
    • Percent change in liver fat (MRI-PDFF) from baseline to week 24 (study arm 2) in patients with baseline liver fat (MRI-PDFF) >/= 8.5%
    • Percent change in liver fat (MRI-PDFF) from baseline to week 12 (study arm 2) and from week 12 to week 24 (study arm 1) in patients with baseline liver fat (MRI-PDFF) >/= 8.5%
    • Change on the daily lipodystrophy hunger questionnaire from baseline to week 12 and week 24
    • The incidence and severity of treatment-emergent adverse events (TEAEs)
    • Concentrations of REGN4461 in serum over time
    • Immunogenicity of REGN4461 over time compared to placebo
    Los siguientes criterios de valoración secundarios se analizarán en la cohorte B y en la población combinada de las cohortes A y B:
    • Cambio porcentual de los TG séricos en ayunas desde el momento basal hasta la semana 12 en pacientes con TG en ayunas basales elevados
    • Cambio absoluto de la HbA1c desde el momento basal hasta la semana 12 en pacientes con HbA1c basal elevada
    Los siguientes criterios de valoración secundarios se analizarán en las cohortes A y B por separado y en la población combinada de las cohortes A y B:
    • Cambio porcentual de los TG séricos en ayunas desde el momento basal hasta la semana 12 en comparación con el cambio porcentual entre la semana 12 y la semana 24 (grupo 1 del estudio)
    • Cambio porcentual de los TG séricos en ayunas desde el momento basal hasta la semana 24 (grupo 2 del estudio)
    • Cambio porcentual de los TG séricos en ayunas después de las primeras 12 semanas de exposición al REGN4461: desde el momento basal hasta la semana 12 (grupo 2 del estudio) y desde la semana 12 hasta la semana 24 (grupo 1 del estudio; los pacientes deben cumplir los criterios de estabilidad)
    • Cambio de la HbA1c desde el momento basal hasta la semana 12 en comparación con el cambio entre la semana 12 y la semana 24 (grupo 1 del estudio)
    • Cambio de la glucosa en ayunas desde el momento basal hasta la semana 12 en comparación con el cambio entre la semana 12 y la semana 24 (grupo 1 del estudio)
    • Cambio de la HbA1c desde el momento basal hasta la semana 24 (grupo 2 del estudio)
    • Cambio de la glucosa en ayunas desde el momento basal hasta la semana 24 (grupo 2 del estudio)
    • Cambio de la HbA1c desde el momento basal hasta la semana 12 (grupo 2 del estudio) y desde la semana 12 hasta la semana 24 (grupo 1 del estudio; los pacientes deben cumplir los criterios de estabilidad)
    • Cambio de la glucosa en ayunas desde el momento basal hasta la semana 12 (grupo 2 del estudio) y desde la semana 12 hasta la semana 24 (grupo 1 del estudio)
    • Cambio porcentual de la grasa hepática (MRI-PDFF) desde el momento basal hasta la semana 12, con REGN4461 frente a placebo, en pacientes con grasa hepática (MRI-PDFF) basal >/= 8,5%.
    • Cambio porcentual de la grasa hepática (MRI-PDFF) desde el momento basal hasta la semana 12 en comparación con el cambio porcentual entre la semana 12 y la semana 24 (grupo 1 del estudio) en pacientes con grasa hepática (MRI-PDFF) basal >/= 8,5%.
    • Cambio porcentual de la grasa hepática (MRI-PDFF) desde el momento basal hasta la semana 24 (grupo 2 del estudio) en pacientes con grasa hepática (MRI-PDFF) basal >/= 8,5%.
    • Cambio porcentual de la grasa hepática (MRI-PDFF) desde el momento basal hasta la semana 12 (grupo 2 del estudio) y desde la semana 12 hasta la semana 24 (grupo 1 del estudio) en pacientes con grasa hepática (MRI-PDFF) basal >/= 8,5%.
    • Cambio en el cuestionario diario sobre apetito en la lipodistrofia desde el momento basal hasta la semana 12 y la semana 24
    • Incidencia y severidad de acontecimientos adversos surgidos en el tratamiento (treatment-emergent adverse events, TEAE)
    • Concentraciones séricas de REGN4461 a lo largo del tiempo
    • Inmunogenia del REGN4461 a lo largo del tiempo en comparación con placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    As Stated Above
    Como se indicó anteriormente
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.1.1First administration to humans No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Turkey
    United States
    France
    Spain
    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
    The end of study is defined as the date the last patient either completes the last study visit, withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    Se define el final del estudio como la fecha en que el último paciente complete la última visita del estudio, se retire del estudio o se pierda para el seguimiento (es decir, el investigador ya no consigue ponerse en contacto con el paciente).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 40
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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