Trials / Completed
CompletedNCT05894148
Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults
A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
Detailed description
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Genakumab injection | Group 1: 120mg Q4W，group 2: 200mg Q4W |
| DRUG | placebo | The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection. |
Timeline
- Start date
- 2023-03-06
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2023-06-08
- Last updated
- 2025-04-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05894148. Inclusion in this directory is not an endorsement.