Clinical trial NCT03320707: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Must have a body weight in the range of 50 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m\^2), inclusive, at screening and Day -1
* Must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -1
* Must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1
* A woman must not be of childbearing potential
* Must be a non-smoker or tobacco user or 3 months prior to screening

Exclusion Criteria:

* Pregnant or breastfeeding while enrolled in this study or within 20 weeks after the dose of study treatment
* History of or currently has any clinically significant medical illness or medical disorders the investigator considers significant, including, but not limited to immune deficiency state, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
* Active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
* Has had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening and/or plan to receive a BCG vaccine within 12 months after the administration of study treatment
* Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months
* Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) zoster within the past 5 years
* Has received prescription medications within 14 days prior to study treatment

Primary outcomes:
measure: Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo
timeFrame: Up to Day 141
measure: Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo
timeFrame: Up to Day 141
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 predose through Day 141
measure: Time to the Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1 predose through Day 141
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last])
timeFrame: Day 1 predose through Day 141
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity])
timeFrame: Day 1 predose through Day 141
measure: Number of Participants With Anti-daratumumab Antibodies
timeFrame: Day 1 predose through Day 141
measure: Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
timeFrame: Day 1 predose through Day 141
measure: Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry
timeFrame: Day 1 predose through Day 141
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: