Idiopathic Pulmonary Fibrosis/Progressive Pulmonary FibrosisPhase 1NCT06821464
A Trial of HRS-9813 in Healthy Subjects
A Phase 1 study testing HRS-9813 in people with Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in 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
- Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis
- What is being tested?
- HRS-9813
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to 27 Jul 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
- Voluntarily sign the informed consent form before the start of activities related to this trial, and be able to fully understand the procedures, methods, contents and possible adverse reactions of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial.
- Aged 18-45 years (inclusive), healthy male or female;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (inclusive), body mass index (BMI) = weight (kg)/(height/100)2 (m2);
- Physical examination, vital signs, 12-lead electrocardiogram, chest anteroposterior and lateral radiographs, abdominal ultrasound and laboratory tests during the screening and baseline periods were normal, or slightly abnormal but clinically insignificant as determined by the researchers;
- Female subjects with fertility and male subjects whose partners are women of childbearing age have taken contraceptive measures within 2 weeks before signing the informed consent form, and are willing to abstain from sex or agree to contraception from the signing of the informed consent form until the end of the follow-up period (non-drug contraception is required during the trial, see Section 13.1.2 for details), and have no plans to have children or donate sperm/eggs.
Who cannot join
- -
- The following diseases or treatment history:
- Any serious clinical diseases such as urinary system, circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic disorders in the past or currently, or any other diseases that the investigators judge may interfere with the results of the trial, such as intestinal diseases (including irritable bowel syndrome) and urinary tract infection/stones, etc.;
- History of malignant tumors (cancers that have been confirmed to have been cured or relieved for ≥5 years, except for radically resected basal cell or squamous cell skin cancer, cervical cancer in situ and resected colon polyps);
- Any conditions or diseases that affect the absorption, metabolism and/or excretion of the study drug;
- Severe infection, severe trauma or major surgery within 3 months before the screening period or baseline period; or plan to undergo surgery during the trial;
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- Have used any drug in the 2 weeks before the screening or baseline period (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, dietary supplements, vitamin A and its derivatives, etc., excluding other conventional vitamins and occasional use of acetaminophen), or still within 5 half-lives of the drug during the screening or baseline period (whichever is longer); plan to use non-test drugs during the trial;
- Participated in clinical trials of any other drugs or medical devices within 3 months before the screening or baseline period or planned to participate in the study period, or still within 5 half-lives of the drug during the screening or baseline period (whichever is longer);
- Any of the following examinations during screening meet the following criteria:
- During the screening or baseline period, sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <60 mmHg;
- During the screening or baseline period, orthostatic hypotension occurs (retest within 15 minutes to confirm);
- During the screening or baseline period, abnormal and clinically significant 12-lead electrocardiogram results, male QTcB>450ms, female QTcB>460ms;
- During the screening or baseline period, serum creatinine exceeding the upper limit of normal (ULN);
- During the screening or baseline period, eGFR < 70 mL/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2) = 175×(serum creatinine/88.4)-1.234×age-0.179×(0.79 female), where serum creatinine units are μmol/L);
- During the screening or baseline period, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 1.2 times ULN, or total bilirubin exceeding 1.5 times ULN;
- During the screening period, any one of the following items is positive: hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus antibody, syphilis spirochete antibody or hepatitis C virus antibody;
- General situation:
- Pregnant or lactating women, or positive pregnancy test results during the screening period/baseline period;
- History of blood donation or severe blood loss (blood loss ≥400 mL) within 8 weeks before the screening period or baseline period, or have received blood transfusion within 4 weeks before the screening period or baseline period; or intend to donate blood during the trial;
- Have been vaccinated within 2 weeks before the screening period or baseline period or plan to be vaccinated during the trial;
- History of smoking (average daily smoking >5 cigarettes) within 4 weeks before the screening period or baseline period, or cannot stop using any tobacco products during the trial;
- Average daily alcohol intake exceeds 15 g (15 g alcohol is equivalent to 450 mL beer, 150 mL of wine or about 50mL of low-alcohol liquor), or cannot abstain from alcohol during the trial; or positive alcohol breath test at baseline;
- History of drug abuse or drug dependence before the screening period or baseline period; or positive urine drug test at baseline;
- Drink excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups per day, 250 mL per cup) within 6 months before the screening period or baseline period;
- Have consumed special foods (such as grapefruit, grapefruit juice or foods/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated foods or beverages) within 48 hours before the baseline period;
- Have special dietary requirements and cannot follow a unified diet;
- Have difficulty swallowing, difficulty in venous blood collection, or physical conditions that cannot withstand intensive blood collection;
- Other situations in which the researcher determines that the subject is not suitable for participating in this trial, including but not limited to the following: any physical or psychological disease or condition that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of HRS-9813 After Multiple Oral Administration in Healthy Subjects-A Phase I Clinical Study
The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.
- Being tested
- HRS-9813
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9813Drug
Initial dose to planned dose（low dose）
HRS-9813Drug
Initial dose to planned dose（high dose）
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Low dose Receives: Drug: HRS-9813 |
| Treatment group B | Experimental | High dose Receives: Drug: HRS-9813 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes: Incidence and severity of AEs.
Measured: Day -14 to Day 22
Secondary outcomes (11)
Area under the drug-time curve
Measured: Day 1 to Day 22
Area under the steady-state drug-time curve within the dosing interval
Measured: Day 1 to Day 22
Peak concentration
Measured: Day 1 to Day 22
Time to peak
Measured: Day 1 to Day 22
Half-life
Measured: Day 1 to Day 22
Apparent clearance
Measured: Day 1 to Day 22
Apparent volume of distribution
Measured: Day 1 to Day 22
Steady-state trough concentration
Measured: Day 1 to Day 22
Steady-state peak concentration[
Measured: Day 1 to Day 22
Accumulation ratio (Racc)
Measured: Day 1 to Day 22
Proportion of subjects experiencing hypotension during the study
Measured: Day 1 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start17 Feb 2025
- Primary completion27 Jul 2025
- Study completion27 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis/Progressive Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 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
- NCT06821464
- Sponsor's protocol ID
- HRS-9813-102
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 2 Jul 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of HRS-9813 After Multiple Oral Administration in Healthy Subjects-A Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT06821464
- Acronym / sponsor ID
- HRS-9813-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 27 Jul 2025 (actual)
- First posted
- 12 Feb 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.
The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS-9813Low dose |
| Treatment group B | Experimental | Drug: HRS-9813High dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily sign the informed consent form before the start of activities related to this trial, and be able to fully understand the procedures, methods, contents and possible adverse reactions of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial.
- Aged 18-45 years (inclusive), healthy male or female;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (inclusive), body mass index (BMI) = weight (kg)/(height/100)2 (m2);
- Physical examination, vital signs, 12-lead electrocardiogram, chest anteroposterior and lateral radiographs, abdominal ultrasound and laboratory tests during the screening and baseline periods were normal, or slightly abnormal but clinically insignificant as determined by the researchers;
- Female subjects with fertility and male subjects whose partners are women of childbearing age have taken contraceptive measures within 2 weeks before signing the informed consent form, and are willing to abstain from sex or agree to contraception from the signing of the informed consent form until the end of the follow-up period (non-drug contraception is required during the trial, see Section 13.1.2 for details), and have no plans to have children or donate sperm/eggs.
Key exclusion criteria (28 listed)
- -
- Any serious clinical diseases such as urinary system, circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic disorders in the past or currently, or any other diseases that the investigators judge may interfere with the results of the trial, such as intestinal diseases (including irritable bowel syndrome) and urinary tract infection/stones, etc.;
- History of malignant tumors (cancers that have been confirmed to have been cured or relieved for ≥5 years, except for radically resected basal cell or squamous cell skin cancer, cervical cancer in situ and resected colon polyps);
- Any conditions or diseases that affect the absorption, metabolism and/or excretion of the study drug;
- Severe infection, severe trauma or major surgery within 3 months before the screening period or baseline period; or plan to undergo surgery during the trial;
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-9813Initial dose to planned dose（low dose） | Drug | Treatment group A |
| HRS-9813Initial dose to planned dose（high dose） | Drug | Treatment group B |
Primary outcome
Safety outcomes: Incidence and severity of AEs.
Time frame: Day -14 to Day 22
11 secondary outcomes
Area under the drug-time curve
Time frame: Day 1 to Day 22
Area under the steady-state drug-time curve within the dosing interval
Time frame: Day 1 to Day 22
Peak concentration
Time frame: Day 1 to Day 22
Time to peak
Time frame: Day 1 to Day 22
Half-life
Time frame: Day 1 to Day 22
Apparent clearance
Time frame: Day 1 to Day 22
Apparent volume of distribution
Time frame: Day 1 to Day 22
Steady-state trough concentration
Time frame: Day 1 to Day 22
Steady-state peak concentration[
Time frame: Day 1 to Day 22
Accumulation ratio (Racc)
Time frame: Day 1 to Day 22
Proportion of subjects experiencing hypotension during the study
Time frame: Day 1 to Day 22
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 2 Jul 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 in people with Idiopathic Pulmonary Fibrosis/Progressive 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 5 inclusion and 28 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 2 Jul 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?
Safety outcomes: Incidence and severity of AEs. (time frame: Day -14 to Day 22). 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 2 Jul 2026.