A Phase 1 Open-label, Randomized, study of Rocatinlimab (AMG 451) in Healthy Subjects
Research type
Research Study
Full title
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
IRAS ID
1009158
Contact name
Tabitha Catuna
Contact email
Sponsor organisation
Amgen Inc.
Research summary
The Study Drug (Rocatinlimab or AMG 451) is an investigational drug being developed by the sponsor as a potential treatment for Atopic Dermatitis (Eczema) and possibly other immune-mediated diseases (overactivity of the immune system). Atopic dermatitis (AD) is a chronic inflammatory skin disease which is prevalent worldwide. The mechanism of the disease is now understood to be excessive activation of parts of the immune system. Rocatinlimab is a monoclonal antibody which works by regulating the immune system (preventing excessive activation) hence may play a role in treating AD. There are several available treatments for AD however for some patients these are not very effective or can cause side effects. It is hoped that the Study Drug will be more effective with fewer side effects than currently available options. The purpose of this study is to determine the relative bioavailability (compare blood drug levels) of rocatinlimab vials and rocatinlimab prefilled syringes. The prefilled syringe will provide an alternative device for drug administration and potentially help with patient convenience. In both cases the Study Drug will be given as 300 mg single dose SC (under the skin) injection.
Approximately 433 subjects have received at least 1 dose of rocatinlimab in the completed studies so far, including healthy subjects, and patients with AD, plaque psoriasis, and ulcerative colitis. This will be a Phase 1, multi-center trial to be conducted across 4 research sites in the United States and United Kingdom and will involve approximately 230 subjects overall. Planned study duration (from screening to end of study visit) is approximately 20 weeks.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0003
Date of REC Opinion
19 Mar 2024
REC opinion
Further Information Favourable Opinion