Trials / Completed
CompletedNCT02665637
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
A Randomized, Double-blind, Two-arm, Parallel-group, Single Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Two Formulations of Trastuzumab (CT-P6 and US-licensed Herceptin) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a double-blind, two-arm, parallel-group, single-dose study.
Detailed description
This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy male subjects will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab | Each patient may receive single dose by intravenous infusion |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2016-01-28
- Last updated
- 2016-08-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02665637. Inclusion in this directory is not an endorsement.