Health TrialsbyHealthPanel

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

ConditionsCoronary Artery Disease (CAD)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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • SRSD107

    Drug

    Administered S.C.

  • 0.9 % sodium chloride

    Drug

    Administered S.C.

Treatment groups

104 Participants
are divided into 5 treatment groups
Group A: SRSD107 dose level 1Experimental treatment 1 intervention
Group B: SRSD107 dose level 2Experimental treatment 1 intervention
Group C: SRSD107 dose level 3Experimental treatment 1 intervention
Group D: SRSD107 dose level 4Experimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in time-averaged FXI antigen

Time frame
72 weeks

Secondary outcomes

1

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

Time frame
72 weeks
2

Maximal concentration of SRSD107

Time frame
72 weeks
3

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

Time frame
72 weeks
4

Time to the maximal concentration of SRSD107

Time frame
72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sirius Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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