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

NCT ID: NCT07040787

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2025-08-17

Brief Summary

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

Conditions

Complement Mediated Glomerular Diseases; Hemolytic Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-drug interaction between HRS-5965 and clopidogrel

Group Type: EXPERIMENTAL

HRS-5965 Capsules

Intervention Type: DRUG

Oral HRS-5965 capsules.

Clopidogrel

Intervention Type: DRUG

Oral clopidogrel.

Drug-drug interaction between HRS-5965 and clarithromycin

Group Type: EXPERIMENTAL

HRS-5965 Capsules

Intervention Type: DRUG

Oral HRS-5965 capsules.

Clarithromycin

Intervention Type: DRUG

Oral clarithromycin.

Interventions

HRS-5965 Capsules

Oral HRS-5965 capsules.

Intervention Type: DRUG

Clopidogrel

Oral clopidogrel.

Intervention Type: DRUG

Clarithromycin

Oral clarithromycin.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chengdu Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

HRS-5965-107

Identifier Type: -

Identifier Source: org_study_id