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    Summary
    EudraCT Number:2020-003796-17
    Sponsor's Protocol Code Number:CST103/CST139-CLIN-010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-003796-17
    A.3Full title of the trial
    An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory.
    A.4.1Sponsor's protocol code numberCST103/CST139-CLIN-010
    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 SponsorCuraSen 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 supportCuraSen Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCuraSen Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address2655 Campus Drive, Suite 110
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94403
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650475 2842
    B.5.6E-mailclinicaltrials@curasen.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 Yes
    D.2.1.1.1Trade name Spiropent
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameClenbuterol HCl
    D.3.2Product code CST-103
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLENBUTEROL HYDROCHLORIDE
    D.3.9.1CAS number 21898-19-1
    D.3.9.2Current sponsor codeCST-103
    D.3.9.4EV Substance CodeSUB01339MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.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 Yes
    D.2.1.1.1Trade name Berachin
    D.2.1.1.2Name of the Marketing Authorisation holderNipro ES Pharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameTulobuterol
    D.3.2Product code CST-139
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTolubuterol Hydrochloride
    D.3.9.1CAS number 56776-01-3
    D.3.9.2Current sponsor codeCST-139
    D.3.9.3Other descriptive nameTULOBUTEROL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05010MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Patients with Mild Cognitive Impairment or Parkinson’s Disease
    E.1.1.1Medical condition in easily understood language
    Patients with mild memory problems and patients with Parkinson's disease.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are:
    Part A
    To evaluate the effects of CST-139 on cerebral perfusion in healthy subjects.
    Part B
    To evaluate the effects of multiple doses of CST-139 on cerebral perfusion in subjects with Mild Cognitive Impairment (MCI) or Parkinson’s Disease (PD).
    Part C
    To evaluate the effects of multiple doses of CST-103 on cerebral perfusion in subjects with MCI or PD.
    E.2.2Secondary objectives of the trial
    The secondary objectives include the following:
    Part A
    1. To examine the effects of CST-139 on cognition in healthy subjects
    2. To assess the safety and tolerability of CST-139
    3. To characterize the pharmacokinetic (PK) profile of CST-139
    Part B
    1. To examine the effects of multiple doses of CST-139 on cognition in subjects with MCI or PD
    2. To assess the safety and tolerability of CST-139
    3. To characterize the PK profile of CST-139
    Part C
    1. To examine the effects of multiple doses of CST-103 on cognition in subjects with MCI or PD
    2. To assess the safety and tolerability of CST-103
    3. To characterize the PK profile of CST-103
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A – healthy subjects
    A subject will be considered eligible for enrollment if all of the following criteria are met:
    1. Males and females aged 40-75 years (inclusive) at the time of informed consent
    2. Body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive at Screening
    3. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.
    Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the End of Study Visit
    4. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from 30 days prior to Day 1 through 30 days after the last study medication administration:
    a. use a reliable method of birth control, or
    b. monogamous relationship with a male partner of confirmed sterility, or
    c. practice complete abstinence
    5. Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal or have undergone surgical sterilization
    6. Subject is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory assessments conducted at Screening
    7. Able to speak, read and understand English
    8. Able to understand and sign the written informed consent form (ICF)
    9. Willing to follow the protocol requirements and comply with protocol restrictions
    Parts B and C – subjects with MCI or PD
    MCI or PD subjects must meet the following criteria:
    10. Males and females aged 40-75 years (inclusive) at the time of informed consent
    11. Montreal Cognitive Assessment (MoCA) score ≥18 and ≤26
    12. Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the End of Study Visit.
    13. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration:
    a. use a reliable method of birth control, or
    b. monogamous relationship with a male partner of confirmed sterility, or
    c. practice complete abstinence
    14. Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal or have undergone surgical sterilization
    15. Stable medical conditions for 3 months prior to Screening visit (e.g., diabetes, hypertension, dyslipidemia)
    16. If already being administered, vitamin E (up to 400 IU daily), estrogens, aspirin (75-300 mg daily), blood pressure medications (except for adrenergic agents), diabetic medications, and cholesterol-lowering agents for 3 months prior to screening is allowed.
    17. In generally good health, in the opinion of the Investigator, based on medical and surgical history, BMI, physical examination, vital signs, 12-lead ECG, and laboratory values, including hematology and chemistry values conducted at Screening.
    18. Clinical laboratory values within normal limits or, if abnormal, must be judged to be clinically insignificant by the Investigator
    19. Able to speak, read and understand English
    20. Able to understand and sign the written ICF
    21. Willing to follow the protocol requirements and comply with protocol restrictions.
    E.4Principal exclusion criteria
    A subject with any of the following criteria will not be eligible for participation.
    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
    2. History of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
    3. A calculated creatinine clearance of ≤70 mL/min according to the Cockcroft-Gault
    equation.
    4. Uncontrolled hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 mmHg) at Screening or Day -1.
    5. History of drug or alcohol abuse ≤12 months prior to Screening.
    6. A positive test for drugs of abuse or alcohol during Screening.
    7. Unwilling or unable to abstain from alcohol from 2 days prior to Day 1 until end-of-study assessments.
    8. Use of over-the-counter medication (other than paracetamol up to 2 g per day), or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the CuraSen Medical Monitor.
    9. Subjects on monoamine oxidase type B inhibitors, dopamine agonists or catechol-O-methyltransferase inhibitors are not allowed.
    10. Current or prior treatment with any beta agonists or beta blockers within the last month prior to Day 1.
    11. Opioid use within 1 month prior to screening or during the study.
    12. Use of St. John’s Wort or Ginkgo Biloba within 1 month prior to study enrollment.
    13. Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening). Subjects with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
    14. Positive screening test for human immunodeficiency virus (HIV).
    15. Positive screening test for or current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or documented history of prior infection.
    16. Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is above 1.5 X above the upper limit of normal, or any out-of-range value for serum sodium or potassium. Screening tests may be repeated once at the discretion of the Investigator.
    17. Clinically significant laboratory or ECG abnormality that could be a safety issue in the study, including QT using Fredericia’s correction of QT interval (QTcF) >450 msec (males) or >470 msec (females).
    18. History of angina, heart failure, coronary insufficiency, cardiac arrythmias, hyperthyroidism, hypothyroidism, or convulsion disorders.
    19. Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrolment in any other study treatment or disease study.
    20. Donation or loss of ≥500 mL of blood or plasma within 30 days prior to dosing.
    21. Inability to undergo a clinical MRI of the brain due to claustrophobia, or other contraindications to undergoing an MRI of the brain including, but not limited to, pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; and, other magnetic, electronic or mechanical implants or clinical findings that in the judgment of the investigator would pose a potential hazard in combination with MRI. The inability to lie supine for a prolonged time period.
    22. Clinically significant abnormal MRI done at Screening or in the past 6 months
    23. Any other reason for which the Principal Investigator considers it is not in the best interest of the participant to undertake the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are:
    Part A
    The change in cerebral perfusion after oral administration of CST-139 as measured by Arterial Spin Labeling (ASL) MRI in healthy subjects.
    Part B
    The change in cerebral perfusion after oral administration of multiple doses of CST-139 as measured by ASL MRI in subjects with MCI or PD.
    Part C
    The change in cerebral perfusion after oral administration of multiple doses of CST-103 as measured by ASL MRI in subjects with MCI or PD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the protocol for details.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1. CANTAB cognitive assessments, which include the following:
    • Reaction Time (RTI)
    • Verbal Recognition Memory (VRM) Phase I
    • Adaptive Tracking Task (ATT)
    • Paired Associates Learning Task (PAL)
    • Delayed Verbal Recall
    2. Adverse events, ECGs, vitals, laboratory safety tests
    3. Plasma PK parameters of CST-103 and CST-139 (including Cmax, tmax, AUCt, AUCinf , t1/2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the protocol for details.
    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 No
    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) 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 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 trial3
    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 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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state32
    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
    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 Decision2020-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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