Celerion
Tempe, Arizona, 85283, United States
NCT Number: NCT03320707
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
Other names: JNJ-54767414
Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
Time frame: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Time frame: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Time frame: Day 1 predose through Day 141
Cmax is the maximum observed plasma concentration.
Time frame: Day 1 predose through Day 141
Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time frame: Day 1 predose through Day 141
AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time corresponding to the last quantifiable serum concentration.
Time frame: Day 1 predose through Day 141
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinity with extrapolation of the terminal phase, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Day 1 predose through Day 141
Number of participants who test positive for anti-daratumumab antibodies will be reported.
Time frame: Day 1 predose through Day 141
Number of participants who test positive for anti-rHuPH20 antibodies will be reported.
Time frame: Day 1 predose through Day 141
The cluster of differentiation (CD) 38 expression levels and CD38 expressing cell counts, as measured by flow cytometry, will be summarized.
Janssen Research & Development, LLC
Industry
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) 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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