NCT04816513

A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants

An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of Ustekinumab Following a Single Subcutaneous Administration by Two Different Injection Devices in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ustekinumab	Ustekinumab will be administered as SC injection.

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-01-07
• Completion: 2022-01-26
• First posted: 2021-03-25
• Last updated: 2025-04-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study