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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Pulmonary Fibrosis

Treatments: Drug: HRS-9813 Tablet; Drug: HRS-9813 Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06939504

HRS-9813-103

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

HRS-9813 Capsule Group

Experimental group

Treatment:

Drug: HRS-9813 Capsule

HRS-9813 Tablet Group

Experimental group

Treatment:

Drug: HRS-9813 Tablet