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

NCT07040787 | Completed Phase 1

• 1 other identifier: HRS-5965-107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Drug-drug interaction between HRS-5965 and clopidogrel

EXPERIMENTAL

Drug: HRS-5965 Capsules; Drug: Clopidogrel

Drug-drug interaction between HRS-5965 and clarithromycin

EXPERIMENTAL

Drug: HRS-5965 Capsules; Drug: Clarithromycin

Interventions

HRS-5965 Capsules DRUG

Oral HRS-5965 capsules.

Drug-drug interaction between HRS-5965 and clarithromycin; Drug-drug interaction between HRS-5965 and clopidogrel

Clopidogrel DRUG

Oral clopidogrel.

Drug-drug interaction between HRS-5965 and clopidogrel

Clarithromycin DRUG

Oral clarithromycin.

Drug-drug interaction between HRS-5965 and clarithromycin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Aged 18-45 years old on the date of signing the ICF (including the threshold), both male and female.
• 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).
• 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.
• 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).

You may not qualify if:

• Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components.
• 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.
• Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
• Patients with a history of electrolyte disorders (such as hypomagnesemia).
• Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
• Those with a history of meningococcal infection and streptococcus pneumoniae infection.
• Those with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism poisoning) and poliomyelitis.
• Subjects who have had or are currently suffering from active pathological bleeding.
• Subjects with a previous history of recurrent oral ulcers.

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330019, China

Location

MeSH Terms

Conditions

Anemia, Hemolytic

Interventions

Clopidogrel; Clarithromycin

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: July 8, 2025
• Primary Completion: August 17, 2025
• Study Completion: August 17, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CN (1)