Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects

Chengdu Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Complement Mediated Glomerular Diseases; Hemolytic Anemia

Treatments: Drug: HRS-5965 Capsules; Drug: Clopidogrel; Drug: Clarithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07040787

HRS-5965-107

Details and patient eligibility

About

The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
2. Aged 18-45 years old on the date of signing the ICF (including the threshold), both male and female.
3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 19~26 kg/m2 (including the threshold).
4. During the screening period, human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV-Ab) were all negative.
5. Female subjects with reproductive capacity or male subjects whose partners are female subjects with reproductive capacity need to have no plans for fertility or sperm/egg donation within 3 months +1 week for male subjects and 6 months +1 week for female subjects from the date of signing the informed consent form until the last medication use, and voluntarily take efficient contraceptive measures (including partners).

Exclusion criteria

1. Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components.
2. Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance.
3. Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
4. Patients with a history of electrolyte disorders (such as hypomagnesemia).
5. Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
6. Those with a history of meningococcal infection and streptococcus pneumoniae infection.
7. Those with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism poisoning) and poliomyelitis.
8. Subjects who have had or are currently suffering from active pathological bleeding.
9. Subjects with a previous history of recurrent oral ulcers.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Drug-drug interaction between HRS-5965 and clopidogrel

Experimental group

Treatment:

Drug: Clopidogrel

Drug: HRS-5965 Capsules

Drug-drug interaction between HRS-5965 and clarithromycin

Experimental group

Treatment:

Drug: Clarithromycin

Drug: HRS-5965 Capsules