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

April 23, 2026 updated by: Sirius Therapeutics Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:
          • Medical Director
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known bleeding disorder
  • Severe heart failure with known left ventricular ejection fraction <35%, or New York Heart Association (NYHA) class III or IV symptoms.
  • Genetic cardiomyopathies or other non-ischemic cardiomyopathies that are not related to atherosclerotic cardiovascular disease.
  • History of ethanol abuse or addictive drug use (cannabis products allowed) within 6 months of screening.
  • Receipt of an investigational drug (IP) within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study.
  • Previous use of SRSD107.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRSD107 dose level 1
Administered S.C.
Drug: SRSD107
Administered S.C.
Experimental: SRSD107 dose level 2
Administered S.C.
Drug: SRSD107
Administered S.C.
Experimental: SRSD107 dose level 3
Administered S.C.
Drug: SRSD107
Administered S.C.
Experimental: SRSD107 dose level 4
Administered S.C.
Drug: SRSD107
Administered S.C.
Placebo Comparator: Placebo
Administered S.C.
Drug: 0.9 % sodium chloride
Administered S.C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in time-averaged FXI antigen
Time Frame: 72 weeks
72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in FXI antigen, FXI activity and aPTT
Time Frame: 72 weeks
72 weeks
Maximal concentration of SRSD107
Time Frame: 72 weeks
72 weeks
Area under the concentration-time curve from time 0 to infinity of SRSD107
Time Frame: 72 weeks
72 weeks
Time to the maximal concentration of SRSD107
Time Frame: 72 weeks
72 weeks
Incidence of adverse events
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirius Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRSD107-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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