Evaluating HRS-9813 Capsule and Tablet in Healthy Adults

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 study is testing how well a new medication called HRS-9813 works in both capsule and tablet forms in healthy adults and if eating food changes how the body absorbs it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06939504 on ClinicalTrials.gov

What this trial studies

This phase 1 study aims to assess the relative bioavailability of HRS-9813 in both capsule and tablet forms among healthy subjects. It will also investigate how food intake affects the pharmacokinetics of the HRS-9813 capsule. The study will involve healthy adults aged 18-45, who will be monitored for vital signs and laboratory tests to ensure they meet the eligibility criteria. Participants will be required to follow specific guidelines regarding medication use and health status.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-45 with a BMI between 19-26 kg/m2.

Not a fit: Patients with serious clinical diseases or those on medications that affect drug absorption will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved formulations of HRS-9813 for treating pulmonary fibrosis.

How similar studies have performed: While this study focuses on a specific formulation, similar pharmacokinetic studies have shown success in optimizing drug delivery methods.

Eligibility 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.

Where this trial is running

Shanghai, Shanghai

• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ruifang Guan

Conditions Pulmonary Fibrosis