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RecruitingNCT07318155Updated Apr 29, 2026

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

A Phase 2 interventional study of SRSD107 and 0.9 % sodium chloride in Coronary Artery Disease (CAD) and Peripheral Arterial Disease, sponsored by Sirius Therapeutics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Sirius Therapeutics Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2025, registered Dec 2025).
  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease (CAD)
  • Peripheral Arterial Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 104 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Sirius Therapeutics Co., Ltd. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    SRSD107 dose level 1

    Administered S.C.

    Drug: SRSD107

  • Experimental
    SRSD107 dose level 2

    Administered S.C.

    Drug: SRSD107

  • Experimental
    SRSD107 dose level 3

    Administered S.C.

    Drug: SRSD107

  • Experimental
    SRSD107 dose level 4

    Administered S.C.

    Drug: SRSD107

  • Placebo comparator
    Placebo

    Administered S.C.

    Drug: 0.9 % sodium chloride

Interventions

  • DrugSRSD107

    Administered S.C.

  • Drug0.9 % sodium chloride

    Administered S.C.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07318155
Lead sponsor
Sirius Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
Jan 5, 2026
Start date
Mar 11, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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