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

Sirius Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: Peripheral Arterial Disease; Coronary Artery Disease (CAD)

Treatments: Drug: SRSD107; Drug: 0.9 % sodium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT07318155

SRSD107-202

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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104 participants in 5 patient groups, including a placebo group

SRSD107 dose level 1

Experimental group

Description:

Administered S.C.

Treatment:

Drug: SRSD107

SRSD107 dose level 2

Experimental group

Description:

Administered S.C.

Treatment:

Drug: SRSD107

SRSD107 dose level 3

Experimental group

Description:

Administered S.C.

Treatment:

Drug: SRSD107

SRSD107 dose level 4

Experimental group

Description:

Administered S.C.

Treatment:

Drug: SRSD107

Placebo

Placebo Comparator group

Description:

Administered S.C.

Treatment:

Drug: 0.9 % sodium chloride