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

NCT06438263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-01-20

No results posted yet for this study

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

DRUG

Rocatinlimab

Vial supplied as a single-use preservative free solution for SC injection.

DRUG

Rocatinlimab

Autoinjector for SC injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2025-05-03
Completion
2025-07-02
FDA Drug
Yes

Countries

  • United States

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 NCT06438263 on ClinicalTrials.gov