Trials / Completed
CompletedNCT06268860
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocatinlimab vial injection | Vial solution for SC injection administered on Day 1 |
| COMBINATION_PRODUCT | Rocatinlimab prefilled syringe | Prefilled syringe solution for SC injection administered on Day 1 |
Timeline
- Start date
- 2024-02-15
- Primary completion
- 2024-08-30
- Completion
- 2024-10-08
- First posted
- 2024-02-20
- Last updated
- 2025-12-23
Locations
4 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06268860. Inclusion in this directory is not an endorsement.