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

NCT07318155 | Recruiting Phase 2

• 1 other identifier: SRSD107-202
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD); Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in time-averaged FXI antigen

  72 weeks

Secondary Outcomes (5)

• Percent change from baseline in FXI antigen, FXI activity and aPTT

  72 weeks

• Maximal concentration of SRSD107

  72 weeks

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

  72 weeks

• Time to the maximal concentration of SRSD107

  72 weeks

• Incidence of adverse events

  72 weeks

Study Arms (5)

SRSD107 dose level 1

EXPERIMENTAL

Administered S.C.

Drug: SRSD107

SRSD107 dose level 2

EXPERIMENTAL

Administered S.C.

Drug: SRSD107

SRSD107 dose level 3

EXPERIMENTAL

Administered S.C.

Drug: SRSD107

SRSD107 dose level 4

EXPERIMENTAL

Administered S.C.

Drug: SRSD107

Placebo

PLACEBO COMPARATOR

Administered S.C.

Drug: 0.9 % sodium chloride

Interventions

SRSD107 DRUG

Administered S.C.

SRSD107 dose level 1; SRSD107 dose level 2; SRSD107 dose level 3; SRSD107 dose level 4

0.9 % sodium chloride DRUG

Administered S.C.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirius Therapeutics Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 5, 2026
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)