NCT01866007View on ClinicalTrials.gov

A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

May 9, 2013

Primary Completion Date

September 20, 2013

Study Completion Date

October 9, 2013

Conditions
Healthy
Interventions
DRUG

Guselkumab (lyophilized formulation)

Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.

DRUG

Guselkumab (liquid formulation with PFS-U)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.

DRUG

Guselkumab (liquid formulation with PFS FID)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.

DRUG

Guselkumab (liquid formulation)

Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.

Trial Locations (3)

Unknown

Tempe

Lincoln

Neptune City

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01866007 - A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants | Biotech Hunter | Biotech Hunter