A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Subcutaneously Administered SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
Sirius Therapeutics Co., Ltd.
104 participants
Mar 11, 2025
INTERVENTIONAL
Conditions
Summary
The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.
Eligibility
Inclusion Criteria4
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Males or females aged 18 to 75 years, inclusive.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2, inclusive.
- History of chronic coronary and/or peripheral arterial disease
Exclusion Criteria6
- Known bleeding disorder
- Severe heart failure with known left ventricular ejection fraction <35%, or New York Heart Association (NYHA) class III or IV symptoms.
- Genetic cardiomyopathies or other non-ischemic cardiomyopathies that are not related to atherosclerotic cardiovascular disease.
- History of ethanol abuse or addictive drug use (cannabis products allowed) within 6 months of screening.
- Receipt of an investigational drug (IP) within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study.
- Previous use of SRSD107.
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Interventions
Administered S.C.
Administered S.C.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07318155