Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects

Phase 1 Completed 40 enrolled Hangzhou Grand Biologic Pharmaceutical, Inc. Peking Union Medical College Hospital · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers.

Timeline

Start: 2021-03-01
Primary completion: 2021-10-31
Completion: 2022-01-14

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HZBio1	Unknown	0.96 mg/kg	Intramuscular
Subject	HZBio1	Unknown	3 mg/kg	Intramuscular
Subject	HZBio1	Unknown	6 mg/kg	Intramuscular
Subject	HZBio1	Unknown	9 mg/kg	Intramuscular
Subject	HZBio1	Unknown	12 mg/kg	Intramuscular

Indications

No indication recorded.