A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA

Sponsor
Sirius Therapeutics Co., Ltd.
Study ID
NCT07140523
Phase
PHASE2
Status
Recruiting
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Conditions

  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SRSD107 — DRUG
    SRSD107 is an investigational siRNA product for anticoagulants.
  • enoxaparin — DRUG
    Enoxaparin is a low molecular weight heparin \[LMWH\] indicated for Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness.

Study Details

This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA.

Key Dates

First listed
Aug 24, 2025
Start date
Sep 16, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: SRSD107 low dose
    Cohort 1: SRSD107, low dose level, subcutaneous (s.c.), single dose
  • Experimental: SRSD107 medium dose
    Cohort 2: SRSD107, medium dose level, subcutaneous (s.c.), single dose
  • Experimental: SRSD107 high dose
    Cohort 3: SRSD107, high dose level, subcutaneous (s.c.), single dose
  • Active Comparator: Enoxaparin
    Cohort 4: Enoxaparin 40 mg s.c., once a day (q.d.), 12 ±2 days post-surgery

Primary Outcome Measure

Incidence of total venous thromboembolism (VTE) events [ Time Frame: From the date of surgery through 12±2 days after surgery. ]

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