Nucleus Network, Q-Pharm Pty Ltd
Herston, 4006, Australia
NCT Number: NCT04544813
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Herston, 4006, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other names: Bermekimab
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.
Time frame: Up to Week 12
Cmax is the maximum observed plasma concentration.
Time frame: Up to Week 12
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Time frame: Up to Week 12
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
Time frame: Up to Week 12
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Time frame: Up to Week 12
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%).
Time frame: Up to Week 12
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.
Time frame: Up to Week 12
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to Week 12
Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported.
Time frame: Up to Week 12
Number of participants with clinically significant changes ECG will be reported.
Time frame: Up to Week 12
Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.
Time frame: Up to Week 12
Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 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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