Trials / Completed
CompletedNCT06438263
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 231 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocatinlimab | Vial supplied as a single-use preservative free solution for SC injection. |
| DRUG | Rocatinlimab | Autoinjector for SC injection. |
Timeline
- Start date
- 2024-08-06
- Primary completion
- 2025-05-03
- Completion
- 2025-07-02
- First posted
- 2024-05-31
- Last updated
- 2026-01-20
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06438263. Inclusion in this directory is not an endorsement.