A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

NCT04147338 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR108698CNTO1959CRD10032020-003725-32
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Serum Concentration (Cmax)

  Cmax is the maximum observed serum concentration.

  Up to Day 85

• Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])

  AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.

  Up to Day 85

Secondary Outcomes (5)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to 113 days

• Number of Participants with Clinically Significant Vital Signs Abnormalities

  Up to 113 days

• Number of Participants with Clinically Significant Physical Examination Abnormalities

  Up to 113 days

• Number of Participants with Clinically Significant Laboratory Abnormalities

  Up to 113 days

• Number of Participants with Anti-Guselkumab Antibodies

  Up to Day 85

Study Arms (3)

Reference Device: Guselkumab

EXPERIMENTAL

Participants will receive subcutaneous (SC) injections of guselkumab in reference device.

Drug: Guselkumab

Test Device 1: Guselkumab

EXPERIMENTAL

Participants will receive SC injections of guselkumab in test device 1.

Drug: Guselkumab

Test Device 2: Guselkumab

EXPERIMENTAL

Participants will receive SC injections of guselkumab in test device 2.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered subcutaneously.

Also known as: CNTO 1959

Reference Device: Guselkumab; Test Device 1: Guselkumab; Test Device 2: Guselkumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
• Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
• A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
• Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention

You may not qualify if:

• History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurologic or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
• History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence
• Has a current chronic infection, prior history of recurrent infection, or an active infection
• Has previously received guselkumab
• Has a positive urine drug and alcohol screen during screening or at admission (Day -1)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Celerion

Tempe, Arizona, 85283, United States

Location

CRS Clinical Research Services

Mannheim, 68167, Germany

Location

MeSH Terms

Interventions

guselkumab

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: October 30, 2019
• Primary Completion: September 13, 2021
• Study Completion: December 7, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1); DE (1)