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

Healthy Clinical Trial

Official title:

An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147338
• Other study ID #: CR108698
• Secondary ID: CNTO1959CRD10032
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2019
• Est. completion date: December 7, 2021

Study information

• Verified date: February 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: December 7, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Guselkumab
Guselkumab will be administered subcutaneously.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services	Mannheim
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax)	Cmax is the maximum observed serum concentration.	Up to Day 85
Primary	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	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state.	Up to 113 days
Secondary	Number of Participants with Clinically Significant Vital Signs Abnormalities	Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported.	Up to 113 days
Secondary	Number of Participants with Clinically Significant Physical Examination Abnormalities	Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported.	Up to 113 days
Secondary	Number of Participants with Clinically Significant Laboratory Abnormalities	Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.	Up to 113 days
Secondary	Number of Participants with Anti-Guselkumab Antibodies	Number of participants with anti-drug antibodies to guselkumab will be reported.	Up to Day 85