Actively Recruiting
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
Led by Sirius Therapeutics Co., Ltd. · Updated on 2026-04-29
104
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of SRSD107 in adults with chronic coronary artery disease (CAD) and/or peripheral arterial disease (PAD). This Phase 2a study aims to understand how multiple doses of SRSD107 affect the body (pharmacodynamics), how the body processes the drug (pharmacokinetics), and its safety when used alongside aspirin therapy. The trial uses a randomized, double-blind, placebo-controlled design with several sequential groups to carefully assess these factors. Participants will receive subcutaneous injections of SRSD107 at different dose levels or a placebo. The study includes five groups: four experimental dose levels of SRSD107 and one placebo group. All treatments are administered under close monitoring to assess drug levels and effects over time. Throughout the 72-week study period, participants will have regular assessments including blood tests to measure FXI antigen levels, FXI activity, and clotting times (aPTT). Researchers will also track how much SRSD107 is present in the blood, the timing of peak concentrations, and any adverse events. Safety and drug effects will be carefully monitored to understand how SRSD107 works in this patient population.
CONDITIONS
Brief Title
A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent and follow study rules
- Male or female aged 18 to 75 years
- Body mass index (BMI) between 18.0 and 35.0 kg/m2
- History of chronic coronary and/or peripheral arterial disease
You will not qualify if you...
- Known bleeding disorder
- Severe heart failure with left ventricular ejection fraction less than 35% or NYHA class III or IV symptoms
- Genetic or non-ischemic cardiomyopathies unrelated to atherosclerotic cardiovascular disease
- History of ethanol abuse or addictive drug use (except cannabis) within 6 months
- Use of an investigational drug within 30 days or 5 half-lives before dosing
- Previous use of SRSD107
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 72 weeks
Participants receive subcutaneous injections of SRSD107 or placebo at assigned dose levels to evaluate safety and pharmacodynamics.
Trial Site Locations
Total: 1 location
1
Fuwai Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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