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Completed

NCT Number: NCT06939504

A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects

This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-45 years.
  • Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.
  • Subjects not with clinically significant vital signs and laboratory tests.
  • Take contraception measures.

Exclusion criteria

  • Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.
  • Severe infection, severe trauma or major surgery.
  • Any medications in the two weeks before screening or baseline period.
  • History of blood donation or severe blood loss.
  • Have been vaccinated within 2 weeks before the screening or baseline period.
  • History of smoking or excessive alcohol or drug abuse.
  • Other situations that the researcher judges to be unsuitable.

Treatment and study plan

HRS-9813 Capsule

Drug

HRS-9813 capsule.

HRS-9813 Tablet

Drug

HRS-9813 tablet.

Primary outcomes

  1. Maximum observed concentration of HRS-9813 capsule (Cmax)

    Time frame: Day 1-Day 23.

  2. Maximum observed concentration of HRS-9813 tablet (Cmax)

    Time frame: Day 1-Day 23.

  3. Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)

    Time frame: Day 1-Day 23.

  4. Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)

    Time frame: Day 1-Day 23.

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Day 1-Day 23.

  2. Time to Cmax of HRS-9813 capsule (Tmax).

    Time frame: Day 1-Day 23.

  3. Time to Cmax of HRS-9813 tablet (Tmax).

    Time frame: Day 1-Day 23.

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Evaluation of the Relative Bioavailability of HRS-9813 Capsule and Tablet in Healthy Subjects and the Effect of Food on the Pharmacokinetics of HRS-9813 Capsule

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Jul 8, 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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