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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-07-22

Brief Summary

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

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Detailed Description

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Conditions

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IgA Nephropathy Paroxysmal Nocturnal Hemoglobinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-5965 Group A

Group Type EXPERIMENTAL

HRS-5965 Capsules

Intervention Type DRUG

Oral doses of HRS-5965 capsules at fasted and fed conditions.

HRS-5965 Group B

Group Type EXPERIMENTAL

HRS-5965 Capsules

Intervention Type DRUG

Oral doses of HRS-5965 capsules at fasted and fed conditions.

Interventions

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HRS-5965 Capsules

Oral doses of HRS-5965 capsules at fasted and fed conditions.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes