How HRS-9813 interacts with pirfenidone and nintedanib in healthy adults.

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

This trial will test whether taking HRS-9813 changes how pirfenidone and nintedanib are absorbed, distributed, and cleared in healthy adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (industry)
• Locations: 1 site (Xi’an, Shanxi)
• Trial ID: NCT07229716 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional pharmacokinetic drug–drug interaction study in healthy adult volunteers. Participants aged 18–45 with BMI 19–28 will receive HRS-9813 alone and in combination with pirfenidone and nintedanib while serial blood samples are collected to measure drug concentrations. The study compares pharmacokinetic parameters such as Cmax and AUC to determine whether coadministration alters exposure, and monitors safety and tolerability. The trial is conducted at Tangdu Hospital, Fourth Military Medical University and includes screening, dosing periods, and follow-up safety assessments.

Who should consider this trial

Good fit: Healthy adults aged 18–45 who meet the weight and BMI requirements, can agree to contraception, have no allergies to the study drugs, and are willing to follow the protocol are the intended participants.

Not a fit: People with active pulmonary fibrosis seeking therapeutic benefit, children, pregnant or breastfeeding individuals, older adults outside the age range, or those allergic to the study drugs are unlikely to receive direct clinical benefit from participation.

Why it matters

Potential benefit: If no clinically important interactions are found, clinicians could use the results to guide safer co-prescribing and dosing of HRS-9813 with pirfenidone or nintedanib.

How similar studies have performed: Pharmacokinetic interaction studies are a standard and successful approach for guiding dosing of coadministered drugs, although interactions involving the novel compound HRS-9813 have not been previously characterized.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Aged 18-45 years.
3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m2 (including both endpoints).
4. 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:

1. 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).
2. 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.
3. 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).
4. 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.
5. 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.
6. Pregnant or lactating women, or those whose blood pregnancy test results in the screening or baseline phase are positive.
7. 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.
8. 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.
9. Those who have special dietary requirements and cannot follow the uniform diet.
10. Those who have difficulty swallowing, have problems with venous blood collection, or whose physical condition does not allow for intensive blood sampling.
11. Those who have had severe infections, severe trauma or undergone heavy manual surgery within 3 months before the screening period or baseline period; Or those who plan to undergo surgery during the trial period.
12. During the screening period or baseline period, for those with abnormal 12-lead electrocardiogram results and clinical significance, the QTcB of men was \> 450ms and that of women was \> 460 ms.
13. Those who have a history of smoking (smoking more than 5 cigarettes per day on average) within 3 months before the screening period or baseline period, or those who have a smoking history within 4 weeks before the screening period or baseline period, or those who cannot stop using any tobacco products during the trial period.
14. Those who have a history of drug use or drug abuse/dependence before the screening period or baseline period; Or those with positive urine test results during the baseline period.
15. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, 250 mL per cup) within 6 months prior to the screening period or baseline period.

Where this trial is running

Xi’an, Shanxi

• Tangdu Hospital, Fourth Military Medical University — Xi’an, Shanxi, China (RECRUITING)

Study contacts

• Study coordinator: Ruifang Guan

Conditions: Pulmonary Fibrosis