Spots Global Cancer Trial Database for Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

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Trial Identification

Brief Title: Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

Official Title: 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

Study ID: NCT04905667

Conditions

Breast Cancer

Interventions

GB221

Herceptin

Study Description

Brief 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.