CompletedPhase 1

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

China16 participantsStarted 2025-06-30

Plain-language summary

The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed the informed consent form pre-trial.
✓. Aged 18-45 years at signing the informed consent form.
✓. Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.

✕. Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever \> 38°C.
✕. Major trauma/surgery (≤8 weeks) or planned surgery during the study.
✕. Drug abuse history or positive urine drug screen.
✕. Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.

Peak concentration (Cmax) of HRS-5965

Timeframe: Day 1 to Day 13.

Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t)

Timeframe: Day 1 to Day 13.

NCT IDNCT07035665

SponsorChengdu Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-22