A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects

Launched by CHENGDU SUNCADIA MEDICINE CO., LTD. · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how food affects the way the body absorbs and processes a new medicine called HRS-5965, which is taken as a capsule. The goal is to understand if eating before taking the medicine changes how it works in healthy adults. This information will help doctors know the best way to take the medicine in the future.

Adults between 18 and 45 years old who are generally healthy may be eligible to join the study. Participants need to agree to the study rules and, if they can have children, must use effective birth control during the trial. People with recent infections, recent or planned surgeries, a history of drug abuse, or other health concerns may not be able to participate. If you join, you will take the capsules and have tests to see how your body handles the medicine, both with and without food. This study is still not recruiting participants yet, but it aims to gather important information to support the safe use of HRS-5965 in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed the informed consent form pre-trial.
• • 2. Aged 18-45 years at signing the informed consent form.
• • 3. Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.
• Exclusion Criteria:
• • 1. Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever \> 38°C.
• • 2. Major trauma/surgery (≤8 weeks) or planned surgery during the study.
• • 3. Drug abuse history or positive urine drug screen.
• • 4. Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.