Peking University Third Hospital
Beijing, 100089, China
NCT Number: NCT05407818
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.
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Notify Me55 year–75 year
All sexes
Interventional
Phase 1
Beijing, 100089, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-63733657 will be administered as an IV infusion.
Time frame: Up to Week 13
Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
Time frame: Up to Week 13
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. An assessment of severity grade will be made using the following general categorical descriptors: Mild, Moderate, and Severe.
Time frame: Up to Week 17
Percentage of participants with discontinuations due to AEs will be reported.
Time frame: Up to Week 17
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to Week 17
Percentage of participants with clinically significant changes in vital signs (including temperature [axillary], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time frame: Up to Week 17
Percentage of participants with clinically significant changes in ECGs will be reported.
Time frame: Up to Week 17
Percentage of participants with clinically significant changes in clinical safety laboratory parameters (including hematology, chemistry, and urinalyses) will be reported.
Time frame: Up to Week 13
Percentage of participants with anti-drug antibodies to JNJ-63733657 will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese 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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