Trials / Completed
CompletedNCT03242239
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Alteogen, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALT02 | |
| BIOLOGICAL | EU-licensed Herceptin | |
| BIOLOGICAL | US-licensed Herceptin |
Timeline
- Start date
- 2016-02-09
- Primary completion
- 2016-08-04
- Completion
- 2016-09-30
- First posted
- 2017-08-08
- Last updated
- 2017-08-21
Source: ClinicalTrials.gov record NCT03242239. Inclusion in this directory is not an endorsement.