A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSirius Therapeutics Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SRSD107
- 0.9 % sodium chloride
Treatment groups
104 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov