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NCT Number: NCT07318155

A Study of 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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRSD107

Drug

Administered S.C.

0.9 % sodium chloride

Drug

Administered S.C.

Primary outcomes

  1. Percent change from baseline in time-averaged FXI antigen

    Time frame: 72 weeks

Secondary outcomes

  1. Percent change from baseline in FXI antigen, FXI activity and aPTT

    Time frame: 72 weeks

  2. Maximal concentration of SRSD107

    Time frame: 72 weeks

  3. Area under the concentration-time curve from time 0 to infinity of SRSD107

    Time frame: 72 weeks

  4. Time to the maximal concentration of SRSD107

    Time frame: 72 weeks

  5. Incidence of adverse events

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Sirius Therapeutics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 5, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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