New lung Drug's safety check: how does it mix with existing meds?
NCT ID NCT07229716
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new drug called HRS-9813 in 20 healthy volunteers to see how it interacts with two standard treatments for pulmonary fibrosis (lung scarring): pirfenidone and nintedanib. The goal is to measure drug levels in the blood and check for side effects. This study does not treat the disease but provides important safety and dosing information for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-9813, pirfenidone, nintedanib
- What this could lead to
- If successful, this could help determine safe dosing when HRS-9813 is combined with existing pulmonary fibrosis treatments.
- What could go wrong
- This is an early Phase 1 study in healthy people, not patients. It only measures drug levels and safety, not whether the combination works for the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tangdu Hospital, Fourth Military Medical University
RECRUITINGXi’an, Shanxi, 710026, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Patients and families build a living database of pulmonary fibrosis
- Breathing exercises put to the test for scarred lungs
- Can mindfulness ease the emotional toll of pulmonary fibrosis?
- Can a radioactive tracer reveal hidden lung scarring?
- Can AI catch lung scarring that doctors might miss?