Trials / Completed
CompletedNCT05792917
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
Bioequivalence Study of Tafolecimab Injections Manufactured by Two Different Processes in Chinese Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 166 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tafolecimab (a modified manufacturing process) | 450mg，SC，single dose |
| DRUG | tafolecimab (a original manufacturing process) | 450mg，SC，single dose |
Timeline
- Start date
- 2023-03-06
- Primary completion
- 2023-03-26
- Completion
- 2023-08-04
- First posted
- 2023-03-31
- Last updated
- 2023-09-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05792917. Inclusion in this directory is not an endorsement.