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    EudraCT Number:2019-003178-25
    Sponsor's Protocol Code Number:SNSP113-19-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-003178-25
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis
    Fázis II/a, randomizált, kettős vak, placebo-kontrollos vizsgálat az inhalációs SNSP113 biztonságosságának, tolerálhatóságának és hatásának értékelésére cisztás fibrózisos felnőttek esetén
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis
    Az SNSP113 biztonságosságára, tolerálhatóságára és hatásosságára irányuló vizsgálat cisztás fibrózisban
    A.4.1Sponsor's protocol code numberSNSP113-19-201
    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 Sponsor Synspira Therapeutics, 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 supportSynspira Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd
    B.5.2Functional name of contact pointRegulatory Unit
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.4Telephone number+3612990091
    B.5.5Fax number+3612990096
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2144
    D.3 Description of the IMP
    D.3.1Product nameSNSP113
    D.3.2Product code SNSP113
    D.3.4Pharmaceutical form Nebulisation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot assigned
    D.3.9.1CAS number 942196-15-8
    D.3.9.2Current sponsor codePAAG
    D.3.9.3Other descriptive namePAAG15
    D.3.9.4EV Substance CodeSUB190261
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebulisation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis (CF) is a life-threatening genetic disorder that results in the accumulation of thick, sticky mucus in the lungs, clogging airways and leading to infection and chronic inflammation.

    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of multiple ascending doses (MAD) of inhaled SNSP113 administered once-daily for 28 days to adult Cystic Fibrosis (CF) subjects.
    E.2.2Secondary objectives of the trial
    No secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject voluntarily agrees to participate in this study, is able and willing to comply with the protocol and signs a written Ethics Committee (EC) approved informed consent prior to study-specific screening procedures being performed;
    2. Male and female subjects 18 to 65 years of age (inclusive), on the day of signing informed consent;
    3. Documented and confirmed diagnosis of pulmonary CF as defined by CF signs and symptoms AND genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype; or sweat chloride >60 mEq/L;
    4. Body mass index (BMI) of ≥18.0 kg/m2;
    5. Spirometry at Screening demonstrating a forced expiratory volume in 1 second (FEV1) of ≥40% and ≤90% of predicted normal for age, sex, and height;
    6. Stable pulmonary symptoms associated with CF for 28 days prior to Screening and between the Screening visit and Day 1 as determined by Investigator;
    7. Fulfilling the following laboratory criteria at Screening or results that are considered not clinically significant by the Investigator:
    a) hepatic function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transaminase [GGT], bilirubin) ≤3 x upper limit of normal (ULN);
    b) hemoglobin ≥10 g/dL, platelets ≥75,000/mm3, neutrophils ≥1.0 x 109/L;
    c) serum creatinine ≤2.0 mg/dL (177 µmol/L);
    8. Results of ECG recording at Screening are within normal limits or deemed to be not clinically significant by the Investigator;
    9. Able and willing to comply with scheduled visits, treatment plan, study restrictions, spirometry laboratory tests, contraceptive guidelines, and other study procedures as determined by the Investigator;
    10. Female subjects of child-bearing potential must either be sexually inactive (abstinent) from Day -28 until 28 days after the last dose of study product (SNSP113 or placebo) or be willing to use highly effective methods of birth control from Day -14 until 28 days after the last dose of study product. For the purpose of this study highly effective contraception is defined as:
    a) oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal methods of contraception; OR
    b) oral, injected or implanted (progestogen only) hormonal methods of contraception (e.g., Depo-Provera®, Implanon®); OR
    c) placement of an intrauterine device (IUD) or intrauterine system (IUS).
    11. Females of non-childbearing potential must be postmenopausal with documented amenorrhea for at least 1 year prior to dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status OR undergone sterilization procedures at least 6 months prior to dosing such as:
    a) hysteroscopic sterilization;
    b) bilateral tubal ligation or salpingectomy;
    c) hysterectomy;
    d) bilateral oophorectomy.
    12. All male subjects must either be sexually inactive (abstinent) or be willing to use a condom with spermicide during the study from Day 1 until 28 days after the last dose of study product.
    E.4Principal exclusion criteria
    1. Subjects with significant clinical/laboratory/radiological/spirometry sign(s) within 28 days prior to Screening or between the Screening visit and Day 1 that, in the opinion of the Investigator, is indicative of unstable respiratory disease;
    2. Positive screening tests for hepatitis B surface antigen (HBsAG), anti-hepatitis C virus (HCV) antibodies and anti-Human Immunodeficiency Virus (HIV) 1 and 2 antibodies; positive laboratory-confirmed SARS-CoV-2 (COVID-19) infection as determined by RT-PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization;
    3. Any active infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation (PEx), changes in therapy for pulmonary disease, or any non-CF-related illness which results in the initiation of any new therapy within 28 days prior to Screening;
    4. Changes (e.g., dose, frequency, addition of, discontinuation) in the CF baseline therapies within 28 days prior to Screening;
    5. Regular use (>3 times per week) of a high-dose NSAID (e.g., >1.6 g ibuprofen/day) within 28 days prior to Screening or at any time between the Screening visit and Day 1;
    6. Current or former regular smoker (tobacco, e-cigarette, or cannabis products) within the last 6 months;
    7. Not willing to abstain from use of cannabis products for the duration of the study;
    8. History of alcohol or substance abuse in the past 12 months and/or positive drug test at Screening. Presence of drug(s) administered for known conditions are permitted with concurrence from the Sponsor’s medical monitor (e.g., benzodiazepine);
    9. Participation in an interventional clinical trial involving the receipt of an investigational product or device within the 28 days prior to Screening or 6 half-lives of an investigational product, whichever is longer;
    10. Female subjects who are pregnant, have a positive serum pregnancy test at Screening, are lactating or who plan to become pregnant during the study and/or within 90 days after receiving the study product;
    11. History of organ transplantation or listed for organ transplantation;
    12. Subjects requiring supplemental oxygen;
    13. Subjects with previous or current pneumothorax within 3 months or any other condition that would contraindicate the performance of spirometry in the judgement of the Investigator;
    14. Hemoptysis more than 30 mL over 24 h at any time within 28 days prior to Screening or at any time between Screening visit and Day 1;
    15. History of malignancy <5 years prior to signing the informed consent, except for treated basal cell or squamous cell skin cancer or in situ cervical cancer;
    16. Subjects who, per Investigator's judgment, are not ideal clinical trial candidates due to personal reasons (e.g., perceived willingness or ability to comply with protocol and study procedures) that would likely impede the subject's successful study completion.
    17. Sexually active male subjects with female partners of child-bearing potential not willing to use effective methods of birth control during the study from Day -14 until 28 days after the last dose of study product.
    E.5 End points
    E.5.1Primary end point(s)
    • Vital signs (blood pressure, heart rate, respiratory rate)
    • Clinical laboratory evaluations (hematology included complete blood cell count (CBC) with differential and platelet count, serum biochemistry including blood urea nitrogen and creatinine, liver function tests, coagulation profile, and urinalysis)
    • ECG parameters
    • Pulmonary function assessed by spirometry, pulse oximetry
    • PE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 through study completion
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 56
    F.1.3Elderly (>=65 years) No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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)
    Patients will be switched back to standard treatment

    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 Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-14
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