Status:
COMPLETED
Relative Bioavailability Study of HR19042 in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Primary IgA Nephropathy; Autoimmune Hepatitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, open-label, three-period, dual Latin square crossover study. Primary Objective： 1. To evaluate the oral relative bioavailability of HR19042 Capsules compared wit...
Eligibility Criteria
Inclusion
- Male or female subjects, ages 18 to 45, inclusive, at the time of informed consent.
- Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 19.0 and 28.0 kg/m2, inclusive, at screening.
- Understands the study procedures in the informed consent form ICF and be willing and able to comply with the protocol.
Exclusion
- Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs, or allergic disease diagnosed and treated by a physician.
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
- History of any gastrointestinal surgery or cholecystectomy that could impact the PK of study drugs.
- Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
- Blood loss or blood donation of more than 300 mL within 3 months before screening, or intended to donate blood during the trial.
- Those who have been vaccinated with vaccines within 3 month before screening or who have an intention to vaccinate during the trial.
- Difficulty in venous blood sampling or fear of needles/blood.
- Difficulty in swallowing capsules, or inability to comply with the provided diet and study-related instructions.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06922305
Start Date
December 27 2023
End Date
January 25 2024
Last Update
April 22 2025
Active Locations (1)
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1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072