Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 (Recombinant Human Angiotensin-converting Enzyme 2-Fc Fusion Protein for COVID-19) in Healthy Adult Subjects
NCT04583228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2022-04-01
Summary
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
Conditions
- COVID 19
Interventions
- DRUG
-
HLX71
Single-dose, intravenous infusion
- OTHER
-
Placebo
Single-dose, intravenous infusion
Sponsors & Collaborators
-
Hengenix Biotech Inc
lead INDUSTRY
Principal Investigators
-
Frank Lee, MD · Frontage Clinical Services, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-08
- Primary Completion
- 2021-07-15
- Completion
- 2021-07-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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