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

Chengdu Suncadia Medicine Co., Ltd.16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgA Nephropathy Paroxysmal Nocturnal Hemoglobinuria

Interventions

HRS-5965 CapsulesDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Peak concentration (Cmax) of HRS-5965

Time frame: Day 1 to Day 13.

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

Time frame: Day 1 to Day 13.

Secondary Outcomes

Time to peak concentration (Tmax)

Time frame: Day 1 to Day 13.

Adverse events (AEs)

Time frame: Day 1 to Day 20.

Data from ClinicalTrials.gov

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