A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SRSD107, 0.9 % sodium chloride.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD), Peripheral Arterial Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug SRSD107
Administered S.C. - Drug 0.9 % sodium chloride
Administered S.C.
Primary outcome measures
- Percent change from baseline in time-averaged FXI antigen [Time frame: 72 weeks]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fuwai Hospital — Beijing
Identifiers
NCT: NCT07318155 · SRSD107-202