A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

August 19, 2019

Study Completion Date

August 19, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

HD201

Single-dose 6mg/kg body weight by 90 minute intravenous infusion

DRUG

EU-Herceptin

Single-dose 6mg/kg body weight by 90 minute intravenous infusion

DRUG

US-Herceptin

Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Trial Locations (1)

Unknown

Q Pharm, Brisbane

Sponsors
All Listed Sponsors
lead

Prestige Biopharma Limited

INDUSTRY