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A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 45 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged 18-45 years. 2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2. 3. Subjects not with clinically significant vital signs and laboratory tests. 4. Take contraception measures.

Exclusion Criteria:

1. Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug. 2. Severe infection, severe trauma or major surgery. 3. Any medications in the two weeks before screening or baseline period. 4. History of blood donation or severe blood loss. 5. Have been vaccinated within 2 weeks before the screening or baseline period. 6. History of smoking or excessive alcohol or drug abuse. 7. Other situations that the researcher judges to be unsuitable.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06939504
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangdong Hengrui Pharmaceutical Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: HRS-9813 Capsule Group

Experimental: HRS-9813 Tablet Group

Interventions

Drug: - HRS-9813 Capsule

HRS-9813 capsule.

Drug: - HRS-9813 Tablet

HRS-9813 tablet.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.