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

NCT06268860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-08-30
Completion
2024-10-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268860 on ClinicalTrials.gov