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Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

NCT04905667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2021-05-27

No results posted yet for this study

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 ®.

Conditions

Interventions

DRUG

GB221

6 mg/kg, single dose, intravenous infusion, 90-100 min

DRUG

Herceptin

6 mg/kg, single dose, intravenous infusion, 90-100 min

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2020-09-08
Completion
2020-09-11

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905667 on ClinicalTrials.gov