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Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants

ClinicalTrials.gov ID: NCT06438263

Public ClinicalTrials.gov record NCT06438263. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06438263
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Amgen
Industry
Enrollment
231 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 6, 2024 (Actual)
Primary completion
May 3, 2025 (Actual)
Completion
Jul 2, 2025 (Actual)
Last update posted
Jan 20, 2026

2024 – 2025

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Fortrea Clinical Research Unit - Daytona Beach Daytona Beach Florida 32117-5116 —
Fortrea Clinical Research Unit - Dallas Dallas Texas 75247-4968 —
Fortrea Clinical Research Unit Inc. - Madison Madison Wisconsin 53704-2526 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06438263, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 20, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06438263 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →