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

NCT07035665 — Phase 1, Completed, 16 participants, Chengdu Suncadia Medicine Co., Ltd.

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A Single-Center, Randomized, Open-Label, Crossover Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects

Registry	NCT07035665
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	16 (Actual)
Sponsor	Chengdu Suncadia Medicine Co., Ltd. (Industry)
Conditions	IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
Interventions	HRS-5965 Capsules (Drug)
Dates	start 2025-06-30, primary completion 2025-07-22, completion 2025-07-22, first posted 2025-06-25, last updated 2025-08-20
Locations	1 site in China

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
HRS-5965 Group A	Experimental	Drug: HRS-5965 Capsules
HRS-5965 Group B	Experimental	Drug: HRS-5965 Capsules

HRS-5965 Capsules (Drug): Oral doses of HRS-5965 capsules at fasted and fed conditions.

+Outcome measures

Primary outcomes

Peak concentration (Cmax) of HRS-5965 [Day 1 to Day 13.]
Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t) [Day 1 to Day 13.]

Secondary outcomes

Time to peak concentration (Tmax) [Day 1 to Day 13.]
Adverse events (AEs) [Day 1 to Day 20.]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
ZhongShan Hospital FuDan University	Shanghai, Shanghai Municipality	China

My Notes

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