Trials / Completed
CompletedNCT06451848
A Bioequivalence Study of Two Different Dosage Form of Genakumab
A Single Center, Randomized, Double-blind, Single Dose Bioequivalence Trial of Genakumab in Chinese Healthy Male Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Genakumab Injection (T, Solution for injection) | A single dose of subcutaneous injection of Genakumab（Solution for injection, liquid formulation）200 mg on Day 1 |
| DRUG | Genakumab for Injection (R, Powder for solution for injection) | A single dose of subcutaneous injection of Genakumab（Powder for solution for injection, lyophilized formulation) 200 mg on Day 1 |
Timeline
- Start date
- 2024-06-24
- Primary completion
- 2024-11-29
- Completion
- 2025-01-10
- First posted
- 2024-06-11
- Last updated
- 2025-02-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06451848. Inclusion in this directory is not an endorsement.