Trials / Completed
CompletedNCT04670796
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX02 | subject receive one dose of HLX02 |
| DRUG | EU-sourced Trastuzumab (Herceptin®) | subject receive one dose of EU-sourced Trastuzumab (Herceptin®) |
| DRUG | US-licensed Trastuzumab (Herceptin®) | subject receive one dose of US-licensed Trastuzumab (Herceptin®) |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
- First posted
- 2020-12-17
- Last updated
- 2022-06-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04670796. Inclusion in this directory is not an endorsement.