First-in-Human Single Ascending Dose of SHR0302

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Healthy subjects, age 18-45 years (inclusive);

• The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.

Exclusion Criteria:

• Any condition that might interfere with the procedures or tests in the study

• History of heart failure or renal insufficiency

• Smoking; Drug or alcohol abuse