Trials / Completed
CompletedNCT04049409
Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers
A Randomized, Double-blinded, Controlled, Single Dosing Phase I Study to Investigate The Pharmacokinetic, Safety and Immunogenicity Characteristics of CMAB809 and Herceptin in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CMAB809 | CMAB809 will be administered by IV infusion at a single dose of 6mg/kg. |
| DRUG | Trastuzumab | Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg. |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2019-11-20
- Completion
- 2019-11-20
- First posted
- 2019-08-08
- Last updated
- 2020-10-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04049409. Inclusion in this directory is not an endorsement.