RecruitingPhase 1

Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects

China20 participantsStarted 2026-04-04

Plain-language summary

This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntarily sign the informed consent form before the start of the related activities of this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
✓. Aged 18-45 years.
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m2 (including both endpoints).
✓. Sign the informed consent form and, within 28 days after the last administration of the trial drug, have no intention of having children and agree to adopt non-drug methods of effective contraception, and have no plans for sperm donation or egg donation.

Exclusion criteria

✕. Those who are allergic to the study drugs (HRS-9813 capsules, nintedanib or pirfenidone), or any components of the study drugs, or have an allergic constitution (such as individuals with asthma, allergic rhinitis, or eczema).
✕. Those subjects who, in the judgment of the researchers, have any conditions or diseases that may affect the absorption, metabolism, and/or excretion of the study drug.
✕. Those who participated in any clinical trial of other drugs or medical devices within the previous 3 months before the screening period or baseline period, or those whose exposure to the drug is still within 5 half-lives during the study period (whichever is longer).
✕. During the screening period or baseline period, the sitting systolic blood pressure was less than 90 mmHg or the sitting diastolic blood pressure was less than 60 mmHg.
✕. During the screening period, any one of the following being positive: hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody, Treponema pallidum antibody or hepatitis C virus antibody.
✕. Pregnant or lactating women, or those whose blood pregnancy test results in the screening or baseline phase are positive.
✕. Those who have a history of blood donation within 8 weeks before the screening period or the baseline period, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 4 weeks before the screening period or the baseline period; or those who plan to donate blood during the trial.
✕. Those who were vaccinated within the two weeks prior to the screening period or the baseline period, or those who plan to receive the vaccine during the trial process.

What they're measuring

The maximum plasma concentration (Cmax)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to time t (AUC0-t)

Timeframe: From Day 1 to Day 24.

Trial details

NCT IDNCT07229716

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Ruifang Guan

+86-0518-82342973 ruifang.guan.rg1@hengrui.com

View on ClinicalTrials.gov More Pulmonary Fibrosis trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntarily sign the informed consent form before the start of the related activities of this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
✓. Aged 18-45 years.
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m2 (including both endpoints).
✓. Sign the informed consent form and, within 28 days after the last administration of the trial drug, have no intention of having children and agree to adopt non-drug methods of effective contraception, and have no plans for sperm donation or egg donation.

Exclusion criteria

✕. Those who are allergic to the study drugs (HRS-9813 capsules, nintedanib or pirfenidone), or any components of the study drugs, or have an allergic constitution (such as individuals with asthma, allergic rhinitis, or eczema).
✕. Those subjects who, in the judgment of the researchers, have any conditions or diseases that may affect the absorption, metabolism, and/or excretion of the study drug.
✕. Those who participated in any clinical trial of other drugs or medical devices within the previous 3 months before the screening period or baseline period, or those whose exposure to the drug is still within 5 half-lives during the study period (whichever is longer).
✕. During the screening period or baseline period, the sitting systolic blood pressure was less than 90 mmHg or the sitting diastolic blood pressure was less than 60 mmHg.
✕. During the screening period, any one of the following being positive: hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody, Treponema pallidum antibody or hepatitis C virus antibody.
✕. Pregnant or lactating women, or those whose blood pregnancy test results in the screening or baseline phase are positive.
✕. Those who have a history of blood donation within 8 weeks before the screening period or the baseline period, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 4 weeks before the screening period or the baseline period; or those who plan to donate blood during the trial.
✕. Those who were vaccinated within the two weeks prior to the screening period or the baseline period, or those who plan to receive the vaccine during the trial process.

What they're measuring

The maximum plasma concentration (Cmax)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau)

Timeframe: From Day 1 to Day 24.

Area under the concentration curve from time 0 to time t (AUC0-t)

Timeframe: From Day 1 to Day 24.