A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease

Sponsor
Sirius Therapeutics Co., Ltd.
Study ID
NCT07318155
Phase
PHASE2
Status
Recruiting
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Conditions

  • Coronary Artery Disease (CAD)
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SRSD107 — DRUG
    Administered S.C.
  • 0.9 % sodium chloride — DRUG
    Administered S.C.

Study Details

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.

Key Dates

First listed
Jan 5, 2026
Start date
Mar 11, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percent change from baseline in time-averaged FXI antigen [ Time Frame: 72 weeks ]

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