Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Trial of HRS-9813 in Healthy Subjects

Safety, Tolerability and Pharmacokinetics of HRS-9813 After Multiple Oral Administration in Healthy Subjects-A Phase I Clinical Study

A Trial of HRS-9813 in Healthy Subjects (NCT06821464) is a Phase 1 interventional studying Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily sign the willing to sign a consent form 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. 2. Aged 18-45 years (inclusive), healthy male or female; 3. 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); 4. 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; 5. Female subjects with fertility and male subjects whose partners are women of childbearing age have taken contraceptive measures within 2 weeks before signing the willing to sign a consent form form, and are willing to abstain from sex or agree to contraception from the signing of the willing to sign a consent form 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 Should NOT Join This Trial: \- The following diseases or treatment history: 1. 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.; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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. 2. Aged 18-45 years (inclusive), healthy male or female; 3. 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); 4. 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; 5. 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. Exclusion Criteria: \- The following diseases or treatment history: 1. 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.; 2. 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); 3. Any conditions or diseases that affect the absorption, metabolism and/or excretion of the study drug; 4. 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; 5. 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; 6. 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: 7. During the screening or baseline period, sitting systolic blood pressure \<90 mmHg or sitting diastolic blood pressure \<60 mmHg; 8. During the screening or baseline period, orthostatic hypotension occurs (retest within 15 minutes to confirm); 9. During the screening or baseline period, abnormal and clinically significant 12-lead electrocardiogram results, male QTcB\>450ms, female QTcB\>460ms; 10. During the screening or baseline period, serum creatinine exceeding the upper limit of normal (ULN); 11. 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); 12. 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; 13. 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: 14. Pregnant or lactating women, or positive pregnancy test results during the screening period/baseline period; 15. 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; 16. Have been vaccinated within 2 weeks before the screening period or baseline period or plan to be vaccinated during the trial; 17. 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; 18. 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; 19. History of drug abuse or drug dependence before the screening period or baseline period; or positive urine drug test at baseline; 20. 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; 21. 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; 22. Have special dietary requirements and cannot follow a unified diet; 23. Have difficulty swallowing, difficulty in venous blood collection, or physical conditions that cannot withstand intensive blood collection; 24. 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.

Treatments Being Tested

DRUG

HRS-9813

Initial dose to planned dose(low dose)

DRUG

HRS-9813

Initial dose to planned dose(high dose)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai General Hospital
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06821464), the sponsor (Guangdong Hengrui Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06821464 clinical trial studying?

The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06821464?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06821464?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06821464. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06821464. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.