NCT04905667

Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

Detailed description

Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	GB221	6 mg/kg, single dose, intravenous infusion, 90-100 min
DRUG	Herceptin	6 mg/kg, single dose, intravenous infusion, 90-100 min

Timeline

• Start date: 2019-11-13
• Primary completion: 2020-09-08
• Completion: 2020-09-11
• First posted: 2021-05-27
• Last updated: 2021-05-27

Locations

1 site across 1 country: China