NCT05323981

Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection

A Single Center, Randomized, Double-blind, Parallel Controlled Phase I Trial Comparing the Pharmacokinetics and Safety of Two Specifications of HS627 Injection, a Recombinant Humanized Anti-Human Epidermal Growth Factor Receptor Monoclonal Antibody Injection, With PERJETA After a Single 420mg Intravenous Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects

Detailed description

This is a randomized, double-blind, parallel controlled，single-dose phase I study to compare the pharmacokinetics and safety of HS627 (2 specifications) with PERJETA in Chinese healthy male adults

Conditions

• Similarity of Pharmacokinetics and Safety

Interventions

Type	Name	Description
DRUG	HS627(210mg/7ml)	Intravenous drip of 420mg HS627
DRUG	HS627(420mg/14ml)	Intravenous drip of 420mg HS627
DRUG	Perjeta	Intravenous drip of 420mg PERJETA

Timeline

• Start date: 2022-04-11
• Primary completion: 2022-10-09
• Completion: 2022-10-09
• First posted: 2022-04-12
• Last updated: 2023-07-11

Locations

1 site across 1 country: China