Trials / Completed
CompletedNCT04820439
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- The Affiliated Hospital of Qingdao University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) | A single intravenous infusion of HS627 420mg |
| DRUG | Perjeta ® | A single intravenous infusion of Perjeta ®420mg |
Timeline
- Start date
- 2020-10-13
- Primary completion
- 2021-02-01
- Completion
- 2021-03-13
- First posted
- 2021-03-29
- Last updated
- 2021-03-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04820439. Inclusion in this directory is not an endorsement.