Pulmonary FibrosisPhase 1NCT07229716
Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects
A Phase 1 study testing HRS-9813 Capsule, Nintedanib Soft Capsules and Pirfenidone Tablets in people with Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- HRS-9813 Capsule, Nintedanib Soft Capsules and Pirfenidone Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2026to 18 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Those who have special dietary requirements and cannot follow the uniform diet.
- Those who have difficulty swallowing, have problems with venous blood collection, or whose physical condition does not allow for intensive blood sampling.
- 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.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710026
About this study
This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
- Conditions
- Pulmonary Fibrosis
- Being tested
- HRS-9813 Capsule, Nintedanib Soft Capsules, Pirfenidone Tablets
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9813 CapsuleDrug
HRS-9813 capsule, specified dose on specified days.
Nintedanib Soft CapsulesDrug
Nintedanib soft capsules, specified dose on specified days.
Pirfenidone TabletsDrug
Pirfenidone tablets, specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group | Experimental | Not described Receives: Drug: HRS-9813 Capsule; Drug: Nintedanib Soft Capsules; Drug: Pirfenidone Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: From Day 1 to Day 24.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
Measured: From Day 1 to Day 24.
Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau)
Measured: From Day 1 to Day 24.
Area under the concentration curve from time 0 to time t (AUC0-t)
Measured: From Day 1 to Day 24.
Secondary outcomes (4)
Accumulative excretion rate (Ae)
Measured: Day 1, Day 19 and Day 20.
Fractional excretion (Fe)
Measured: Day 1, Day 19 and Day 20.
Renal clearance (CLr)
Measured: Day 1, Day 19 and Day 20.
Adverse events (AEs)
Measured: From Day 1 to Day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start4 Apr 2026
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229716
- Sponsor's protocol ID
- HRS-9813-105
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07229716
- Acronym / sponsor ID
- HRS-9813-105
- Conditions
- Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group | Experimental | Drug: HRS-9813 Capsule, Drug: Nintedanib Soft Capsules, Drug: Pirfenidone Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9813 CapsuleHRS-9813 capsule, specified dose on specified days. | Drug | HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group |
| Nintedanib Soft CapsulesNintedanib soft capsules, specified dose on specified days. | Drug | HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group |
| Pirfenidone TabletsPirfenidone tablets, specified dose on specified days. | Drug | HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: From Day 1 to Day 24.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
Time frame: From Day 1 to Day 24.
Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau)
Time frame: From Day 1 to Day 24.
Area under the concentration curve from time 0 to time t (AUC0-t)
Time frame: From Day 1 to Day 24.
4 secondary outcomes
Accumulative excretion rate (Ae)
Time frame: Day 1, Day 19 and Day 20.
Fractional excretion (Fe)
Time frame: Day 1, Day 19 and Day 20.
Renal clearance (CLr)
Time frame: Day 1, Day 19 and Day 20.
Adverse events (AEs)
Time frame: From Day 1 to Day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-9813 Capsule, Nintedanib Soft Capsules and Pirfenidone Tablets in people with Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) (time frame: From Day 1 to Day 24.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.