Trials / Completed
CompletedNCT05405985
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
A Randomized, Single-Dose, Open-Label, Parallel-Group Study in Healthy Volunteers to Assess the Relative Bioavailability of a Subcutaneous Dose of Nemolizumab When Administered With Auto-Injector Compared to Dual-Chamber Syringe
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors \[AI\] (test) versus dual-chamber syringes \[DCS\] (reference) under controlled conditions in healthy adult subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nemolizumab | Nemolizumab with Auto-Injector (AI). |
| DRUG | Nemolizumab | Nemolizumab with Dual-Chamber Syringe (DCS). |
Timeline
- Start date
- 2022-08-11
- Primary completion
- 2022-11-11
- Completion
- 2022-12-08
- First posted
- 2022-06-06
- Last updated
- 2025-01-03
- Results posted
- 2025-01-03
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05405985. Inclusion in this directory is not an endorsement.