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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Percent change from baseline in time-averaged FXI antigen — 72 weeks
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital
Beijing
China
Recruiting
More Sirius Therapeutics Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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