drugset / Trial / NCT04583228

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 ↗

Phase 1 Completed 32 enrolled Hengenix Biotech Inc
RandomizedSequentialQuadruple-blindOther

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

Timeline

Start
2021-04-08
Primary completion
2021-07-15
Completion
2021-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX71 Protein / enzyme biologic 1 mg/kg Intravenous
Subject HLX71 Protein / enzyme biologic 2.5 mg/kg Intravenous
Subject HLX71 Protein / enzyme biologic 3 mg/kg Intravenous
Subject HLX71 Protein / enzyme biologic 5 mg/kg Intravenous
Subject HLX71 Protein / enzyme biologic 10 mg/kg Intravenous
Subject HLX71 Protein / enzyme biologic 15 mg/kg Intravenous

Indications