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

Phase 1

Completed

• Conditions: IgA Nephropathy; Paroxysmal Nocturnal Hemoglobinuria
• Interventions: Drug: HRS-5965 Capsules

• Registration Number: NCT07035665
• Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Study First Posted: 2025-06-25
• Study Start: 2025-06-30
• Primary Completion: 2025-07-22
• Study Completion: 2025-07-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HRS-5965 Group A	HRS-5965 Capsules	-
HRS-5965 Group B	HRS-5965 Capsules	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to peak concentration (Tmax)	Day 1 to Day 13.
Adverse events (AEs)	Day 1 to Day 20.

Trial Locations

Locations (2)

ZhongShan Hospital FuDan University; 🇨🇳 Shanghai, Shanghai, China

ZhongShan Hospital FuDan University; 🇨🇳 Shanghai, Shanghai, China