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
A randomized, double-blind, single-dose by intravenous administration, placebo-controlled, dose escalation, first-in-human study is proposed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and immunogenicity of HLX71 in healthy subjects. Investigators plan to enroll 10 subjects in each of the 4 dose cohorts at 2.5 mg/kg, 5 mg/ kg, 10 mg/kg and 15 mg/kg, of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the investigational product (IP). A total of 40 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
32
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0
Time frame: up to 28 days
The proportion of subjects undergoing DLT events in each dose cohorts during the DLT observation period
Time frame: Days 1 to 7
PK parameters-Peak concentration
Time frame: 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
PK parameters-Time to peak
Time frame: 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
PK parameters-Areas under the concentration-time curves
Time frame: 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
PK parameters-Terminal elimination rate constant
Time frame: 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
PK parameters-Elimination half-life
Time frame: 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
PK parameters-Clearance (CL)
Time frame: 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
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PK parameters-Volume of distribution
Time frame: 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
The concentration-time curves of plasma Ang1-10
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-9
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-8
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-7
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma aldosterone
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
ADA positive rate
Time frame: Day 15 and 29
NAb positive rate
Time frame: Day 15 and 29