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COMPLETED
NCT06268860
PHASE1

A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-02-15

Completion Date

2024-10-08

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

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

Locations (4)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Fortrea Clinical Research Unit Limited - Leeds

Leeds, LDS, United Kingdom