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Completed

NCT Number: NCT07035665

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

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

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Key information

Conditions

IgA Nephropathy Anemia Anemia, Hemolytic Autoimmune Diseases Bone Marrow Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Immune System Diseases Kidney Diseases Male Urogenital Diseases Myelodysplastic Syndromes Nephritis Paroxysmal Nocturnal Hemoglobinuria Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed the informed consent form pre-trial.
  • Aged 18-45 years at signing the informed consent form.
  • Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.

Exclusion criteria

  • Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever > 38°C.
  • Major trauma/surgery (≤8 weeks) or planned surgery during the study.
  • Drug abuse history or positive urine drug screen.
  • Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.

Treatment and study plan

HRS-5965 Capsules

Drug

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

Primary outcomes

  1. Peak concentration (Cmax) of HRS-5965

    Time frame: Day 1 to Day 13.

  2. 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

  1. Time to peak concentration (Tmax)

    Time frame: Day 1 to Day 13.

  2. Adverse events (AEs)

    Time frame: Day 1 to Day 20.

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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