NCT02581748

A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02 (Open-label Part) and to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US and Germany Sourced; Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HLX02
DRUG	Herceptin

Timeline

• Start date: 2015-09-16
• Primary completion: 2016-05-11
• Completion: 2017-01-25
• First posted: 2015-10-21
• Last updated: 2022-06-03

Locations

1 site across 1 country: China