SRSD107 for people with chronic coronary 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
This trial will test different doses of SRSD107 to see if they are safe and produce the expected drug effects in adults with chronic coronary or peripheral arterial disease who are taking aspirin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sirius Therapeutics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07318155 on ClinicalTrials.gov |
What this trial studies
This Phase 2a, randomized, double-blind, placebo-controlled, sequential-cohort trial administers multiple doses of SRSD107 or placebo to adults with chronic coronary and/or peripheral arterial disease on background aspirin. The main aims are to characterize pharmacodynamics, safety, and pharmacokinetics of repeated dosing, with participants randomized within dose cohorts and blinded to treatment assignment. Key eligibility includes age 18–75, BMI 18–35 kg/m2, and documented CAD and/or PAD, while excluding participants with bleeding disorders, severe heart failure, non-ischemic cardiomyopathies, recent substance abuse, prior SRSD107 exposure, or recent investigational drug use. The trial is sponsored by Sirius Therapeutics and conducted at Fuwai Hospital in Beijing with serial monitoring and blood sampling to measure drug levels and PD markers.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with documented chronic coronary and/or peripheral arterial disease, BMI 18–35 kg/m2, able to consent, and willing to take aspirin as background therapy.
Not a fit: Patients with known bleeding disorders, severe heart failure (LVEF <35% or NYHA class III–IV), non-ischemic genetic cardiomyopathies, recent substance abuse, or prior SRSD107 exposure are unlikely to be eligible or to receive benefit from this trial.
Why it matters
Potential benefit: If SRSD107 is effective and safe, it could provide a new treatment option to improve vascular function or reduce ischemic symptoms in patients with chronic coronary or peripheral arterial disease.
How similar studies have performed: SRSD107 represents an early-phase therapeutic approach in this patient group; while other vascular-targeting drugs have shown benefit in some CAD/PAD populations, SRSD107’s clinical effectiveness in this setting is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Fuwai Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.