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

Phase 2RecruitingNCT07318155

Sirius Therapeutics Co., Ltd.104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Coronary Artery Disease (CAD)Peripheral Arterial Disease

Interventions

SRSD107DRUG

Administered S.C.

0.9 % sodium chlorideDRUG

Administered S.C.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fuwai Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Percent change from baseline in time-averaged FXI antigen

Time frame: 72 weeks

Secondary Outcomes

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

Time frame: 72 weeks

Maximal concentration of SRSD107

Time frame: 72 weeks

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

Time frame: 72 weeks

Time to the maximal concentration of SRSD107

Time frame: 72 weeks

Incidence of adverse events

Time frame: 72 weeks

Data from ClinicalTrials.gov

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