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

A Phase 2a Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Subcutaneously Administered SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07318155

Enrollment

104

Registered

2026-01-05

Start date

2026-01-31

Completion date

2028-12-31

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD), Peripheral Arterial Disease

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.

Interventions

DRUGSRSD107

Administered S.C.

DRUG0.9 % sodium chloride

Administered S.C.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in time-averaged FXI antigen	72 weeks

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026