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

Chengdu Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Paroxysmal Nocturnal Hemoglobinuria; IgA Nephropathy

Treatments: Drug: HRS-5965 Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT07035665

HRS-5965-108

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

HRS-5965 Group A

Experimental group

Treatment:

Drug: HRS-5965 Capsules

HRS-5965 Group B

Experimental group

Treatment:

Drug: HRS-5965 Capsules