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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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
Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2028-12
Participants
Target number of participants: 104
Treatments
Experimental: SRSD107 dose level 1
Administered S.C.
Experimental: SRSD107 dose level 2
Administered S.C.
Experimental: SRSD107 dose level 3
Administered S.C.
Experimental: SRSD107 dose level 4
Administered S.C.
Placebo_comparator: Placebo
Administered S.C.
Related Therapeutic Areas
Sponsors
Leads: Sirius Therapeutics Co., Ltd.