WCCT Global, LLC
Cypress, California, 90630, United States
NCT Number: NCT04667052
The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Cypress, California, 90630, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.
Time frame: Up to Day 113
Cmax is the maximum observed serum concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 113
Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.
Time frame: Up to Day 113
Number of participants with serum antibodies to JNJ-64304500 will be reported.
Janssen Research & Development, LLC
Industry
An Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Different Subcutaneously-Administered JNJ-64304500 Formulations in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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