A Phase 1 interventional study of JNJ-64304500 in Healthy, sponsored by Janssen Research & Development, LLC. Withdrawn at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the pharmacokinetic following single subcutaneous administration of Dose 1 or Dose 2 of JNJ-64304500 in healthy Chinese adult participants.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1.
Drug: JNJ-64304500
Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1.
Drug: JNJ-64304500
Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.
Serum Concentration of JNJ-64304500
Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.
Time frame: Up to Day 113
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to Day 113
Number of Participants with Antibodies to JNJ-64304500
Number of participants with antibodies to JNJ-64304500 will be reported.
Time frame: Up to Day 113
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC