Pulmonary FibrosisPhase 1NCT06939504
A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects
A Phase 1 study testing HRS-9813 Capsule and HRS-9813 Tablet in people with Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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. 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 and HRS-9813 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2025to 23 Jun 2025
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120
About this study
Official 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
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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- HRS-9813 Capsule, HRS-9813 Tablet
- 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.
HRS-9813 TabletDrug
HRS-9813 tablet.
| Study group | Role | What they receive |
|---|---|---|
| HRS-9813 Capsule Group | Experimental | Not described Receives: Drug: HRS-9813 Capsule |
| HRS-9813 Tablet Group | Experimental | Not described Receives: Drug: HRS-9813 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of HRS-9813 capsule (Cmax)
Measured: Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
Measured: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
Measured: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
Measured: Day 1-Day 23.
Secondary outcomes (3)
Adverse events (AEs)
Measured: Day 1-Day 23.
Time to Cmax of HRS-9813 capsule (Tmax).
Measured: Day 1-Day 23.
Time to Cmax of HRS-9813 tablet (Tmax).
Measured: Day 1-Day 23.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start4 May 2025
- Primary completion3 Jun 2025
- Study completion23 Jun 2025
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06939504
- Sponsor's protocol ID
- HRS-9813-103
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2025
- Last updated
- 8 Jul 2025
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06939504
- Acronym / sponsor ID
- HRS-9813-103
- Conditions
- Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 May 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 Apr 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-9813 Capsule Group | Experimental | Drug: HRS-9813 Capsule |
| HRS-9813 Tablet Group | Experimental | Drug: HRS-9813 Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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. | Drug | HRS-9813 Capsule Group |
| HRS-9813 TabletHRS-9813 tablet. | Drug | HRS-9813 Tablet Group |
Primary outcome
Maximum observed concentration of HRS-9813 capsule (Cmax)
Time frame: Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
Time frame: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
Time frame: Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
Time frame: Day 1-Day 23.
3 secondary outcomes
Adverse events (AEs)
Time frame: Day 1-Day 23.
Time to Cmax of HRS-9813 capsule (Tmax).
Time frame: Day 1-Day 23.
Time to Cmax of HRS-9813 tablet (Tmax).
Time frame: Day 1-Day 23.
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 8 Jul 2025.
- 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 and HRS-9813 Tablet 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 7 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 8 Jul 2025. 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?
Maximum observed concentration of HRS-9813 capsule (Cmax) (time frame: Day 1-Day 23.). 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 8 Jul 2025.