Trials / Completed
CompletedNCT04175171
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Genor Biopharma Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Coprelotamab Injection | The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump. |
| DRUG | Trastuzumab Injection | The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump. |
Timeline
- Start date
- 2011-11-07
- Primary completion
- 2012-01-08
- Completion
- 2012-03-08
- First posted
- 2019-11-22
- Last updated
- 2019-12-18
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04175171. Inclusion in this directory is not an endorsement.