A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ 64304500

• Registration Number: NCT04667052
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-14
• Study Start: 2021-01-13
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ 64304500: Reference	JNJ 64304500	Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation.
JNJ 64304500: Test	JNJ 64304500	Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500	Up to Day 113	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.
Maximum Observed Serum Concentration (Cmax) of JNJ-64304500	Up to Day 113	Cmax is the maximum observed serum concentration.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters	Up to Day 113	Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.
Number of Participants with Clinically Significant Abnormalities in Vital Signs	Up to Day 113	Number of participants with clinically significant vital signs (temperature, pulse/heart rate, respiratory rate, and blood pressure: systolic and diastolic) will be reported.
Number of Participants with Clinically Significant Abnormalities in Physical Examinations	Up to Day 113	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.
Number of Participants with Serum Antibodies to JNJ-64304500	Up to Day 113	Number of participants with serum antibodies to JNJ-64304500 will be reported.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to Day 113	An adverse event (AE) 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 events between administration of study drug and up to Day 113 that are absent before treatment or that worsen relative to pre-treatment state.

Trial Locations

Locations (1)

WCCT Global, LLC; 🇺🇸 Cypress, California, United States