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

Not Applicable

Not yet recruiting

• Conditions: Complement Mediated Glomerular Diseases; Hemolytic Anemia
• Interventions: Drug: HRS-5965 Capsules; Drug: Clopidogrel; Drug: Clarithromycin

• Registration Number: NCT07040787
• Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2025-08
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug-drug interaction between HRS-5965 and clopidogrel	HRS-5965 Capsules	-
Drug-drug interaction between HRS-5965 and clopidogrel	Clopidogrel	-
Drug-drug interaction between HRS-5965 and clarithromycin	HRS-5965 Capsules	-
Drug-drug interaction between HRS-5965 and clarithromycin	Clarithromycin	-

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax)	Day 1 to day 12.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)	Day 1 to day 12.

Secondary Outcome Measures

Name	Time	Method
Time to maximum plasma concentration	Day 1 to day 12.
Terminal half-life (t1/2)	Day 1 to day 12.
Incidence and severity of adverse events (AEs)	Day 1 up to day 19.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China