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

Launched by CHENGDU SUNCADIA MEDICINE CO., LTD. · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a new medicine called HRS-5965 interacts with two other commonly used drugs, clopidogrel and clarithromycin, in healthy adults. The goal is to understand if taking these medicines together changes how they work or how the body handles them. This study is an early phase (Phase 1) trial, meaning it focuses on safety and how the drugs behave in the body rather than treating a disease.

To join the study, participants need to be healthy men or women between 18 and 45 years old, with a certain weight and body mass index (BMI) range. They must understand the study, agree to participate, and be willing to use birth control if applicable. People with certain health issues, such as heart problems, allergies to the study drugs, or recent infections, will not be eligible. Participants can expect to follow specific study procedures and take the medicines under close supervision to help researchers learn about possible drug interactions. This study has not started recruiting yet, but it will help ensure that HRS-5965 can be safely used with other medications in the future.

Gender

ALL

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.