Status:
COMPLETED
A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Aged 18-45 years.
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.
- Subjects not with clinically significant vital signs and laboratory tests.
- Take contraception measures.
Exclusion
- Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.
- Severe infection, severe trauma or major surgery.
- Any medications in the two weeks before screening or baseline period.
- History of blood donation or severe blood loss.
- Have been vaccinated within 2 weeks before the screening or baseline period.
- History of smoking or excessive alcohol or drug abuse.
- Other situations that the researcher judges to be unsuitable.
Key Trial Info
Start Date :
May 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06939504
Start Date
May 4 2025
End Date
June 23 2025
Last Update
July 8 2025
Active Locations (1)
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1
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120