A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to
Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of
HLX71 in Healthy Adult Subjects
Primary Outcomes
Measure: Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0 Time: up to 28 days
Measure: The proportion of subjects undergoing DLT events in each dose cohorts during the DLT observation period Time: Days 1 to 7
Secondary Outcomes
Measure: PK parameters-Peak concentration Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Time to peak Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Areas under the concentration-time curves Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Terminal elimination rate constant Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Elimination half-life Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Clearance (CL) Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: PK parameters-Volume of distribution Time: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
Measure: The concentration-time curves of plasma Ang1-10 Time: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
Measure: The concentration-time curves of plasma Ang1-9 Time: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
Measure: The concentration-time curves of plasma Ang1-8 Time: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
Measure: The concentration-time curves of plasma Ang1-7 Time: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
Measure: The concentration-time curves of plasma aldosterone Time: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
Measure: ADA positive rate Time: Day 15 and 29
Measure: NAb positive rate Time: Day 15 and 29