NCT04765995View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

October 31, 2021

Study Completion Date

January 14, 2022

Conditions
Healthy Participants
Interventions
DRUG

HZBio1 0.96mg / kg

HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

DRUG

HZBio1 3mg / kg

HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

DRUG

HZBio1 6mg / kg

HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

DRUG

HZBio1 9mg / kg

HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

DRUG

HZBio1 12mg / kg

HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

DRUG

Placebo

Matching placebo will be administered intramuscularly.

Trial Locations (1)

Unknown

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
collaborator

Peking Union Medical College Hospital

OTHER

lead

Hangzhou Grand Biologic Pharmaceutical, Inc.

INDUSTRY

NCT04765995 - Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects | Biotech Hunter | Biotech Hunter