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

NCT07140523 | Recruiting Phase 2

• 1 other identifier: SRSD107-201
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Incidence of total venous thromboembolism (VTE) events

  Defined as deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), non-fatal and fatal PE, and unexplained death for which PE cannot be excluded.

  From the date of surgery through 12±2 days after surgery.

Secondary Outcomes (8)

• Incidence of major VTE

  From the date of surgery through 12±2 days after surgery and Day 64, respectively.

• Incidence of total VTE events

  From the date of surgery through Day 64.

• Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin

  From the date of surgery through 12±2 days after surgery.

• Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)

  From the Pre-surgical Period through 12±2 days after surgery.

• Incidence of composite of MB, CRNMB, and any bleeding

  From the Pre-surgical Period through 12±2 days after surgery, Day 64, and Day 169, respectively.

Study Arms (4)

SRSD107 low dose

EXPERIMENTAL

Cohort 1: SRSD107, low dose level, subcutaneous (s.c.), single dose

Drug: SRSD107

SRSD107 medium dose

EXPERIMENTAL

Cohort 2: SRSD107, medium dose level, subcutaneous (s.c.), single dose

Drug: SRSD107

SRSD107 high dose

EXPERIMENTAL

Cohort 3: SRSD107, high dose level, subcutaneous (s.c.), single dose

Drug: SRSD107

Enoxaparin

ACTIVE COMPARATOR

Cohort 4: Enoxaparin 40 mg s.c., once a day (q.d.), 12 ±2 days post-surgery

Drug: enoxaparin

Interventions

SRSD107 DRUG

SRSD107 is an investigational siRNA product for anticoagulants.

SRSD107 high dose; SRSD107 low dose; SRSD107 medium dose

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.

Also known as: Clexane, Lovenox

Enoxaparin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent before any study assessment is performed.
• Male and female subjects, of any race, between 60 and 80 years of age, inclusive.
• Body mass index between 18.0 and 35.0 kg/m2, inclusive.
• Eligible to undergo elective primary unilateral TKA under general anesthesia.
• Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA.
• aPTT, PT, and INR within the normal reference range at screening.

You may not qualify if:

• Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
• Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
• History of intracranial, intraspinal, or intraocular bleeding.
• Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.
• Myocardial infarction, DVT, PE, stroke , transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening.
• Uncontrolled blood pressure at the time of screening.
• Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2.
• Liver dysfunction, liver cirrhosis, history of hepatic encephalopathy, esophageal varices, or portocaval shunt.
• Clinically significant anemia at screening.
• Platelet counts \<100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
• Positive test for human immunodeficiency virus (HIV) , positive hepatitis B surface antigen, and/or active hepatitis C at screening.
• Ongoing or anticipated need for anticoagulation or antiplatelet therapy from 7 days prior to surgery through the EoS visit.
• Participation in an interventional clinical study within 5 half-lives of the investigational drug or 30 days prior to screening, whichever is longer.
• Use of any ASO or siRNA products within 1 year prior to screening. Diet and Lifestyle.
• Recent or current history of alcoholism or recreational drug abuse.

Sponsors & Collaborators

• Sirius Therapeutics Co., Ltd.: lead

Study Sites (1)

Hospital Nové Město na Moravě

Nové Město na Moravě, Czechia

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 24, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)