A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease (NCT07318155) | Clinical Trial Compass
RecruitingPhase 2
A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
China104 participantsStarted 2025-03-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Percent change from baseline in time-averaged FXI antigen