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

NCT ID: NCT07318155

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease (CAD) Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SRSD107 dose level 1

Administered S.C.

Group Type EXPERIMENTAL

SRSD107

Intervention Type DRUG

Administered S.C.

SRSD107 dose level 2

Administered S.C.

Group Type EXPERIMENTAL

SRSD107

Intervention Type DRUG

Administered S.C.

SRSD107 dose level 3

Administered S.C.

Group Type EXPERIMENTAL

SRSD107

Intervention Type DRUG

Administered S.C.

SRSD107 dose level 4

Administered S.C.

Group Type EXPERIMENTAL

SRSD107

Intervention Type DRUG

Administered S.C.

Placebo

Administered S.C.

Group Type PLACEBO_COMPARATOR

0.9 % sodium chloride

Intervention Type DRUG

Administered S.C.

Interventions

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SRSD107

Administered S.C.

Intervention Type DRUG

0.9 % sodium chloride

Administered S.C.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirius Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SRSD107-202

Identifier Type: -

Identifier Source: org_study_id

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