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CK-3773274

Phase 1

Obstructive Hypertrophic Cardiomyopathy | Small molecule | Cardiovascular |Milestone Pharmaceuticals Inc.|Last Updated: Jan 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04783766Safety, Tolerability and Pharmacokinetics Study of CK-3773274PHASE1 COMPLETED 28Apr 10, 2021Aug 5, 2021Jan 24, 20251 China
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Study Endpoints
Primary Endpoints
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Reduced Left Ventricular Ejection Fraction (LVEF)
SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Secondary Endpoints
Cmax of CK-3773274 after single and multiple ascending doses
SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
CK-3773274 for Single Ascending Dose (SAD) CohortsEXPERIMENTALSubjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274
Placebo comparator for SAD CohortsPLACEBO_COMPARATORSubjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator
CK-3773274 for Multiple Dose (MD) CohortEXPERIMENTALSubjects will receive multiple doses of CK-3773274
Placebo comparator for MD CohortPLACEBO_COMPARATORSubjects will receive multiple doses of placebo comparator
Interventions
NameTypeDescription
CK-3773274DRUGCK-3773274- Tablets
PlaceboDRUGPlacebo- Tablets
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy Chinese males and females between 18 and 45 years of age, inclusive 2. Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive 3. Acoustic windows adequate for accurate transthoracic echocardiograms 4. Normal cardiac structure and function, as det...

Countries:China
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