A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
NCT ID: NCT03320707
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2017-10-16
2019-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
DOUBLE
Study Groups
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Daratumumab
Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20).
Daratumumab
Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
rHuPH20
Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
Placebo
Participants will receive placebo as a single SC dose in each of first 7 cohorts.
Placebo
Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
Interventions
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Daratumumab
Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
Placebo
Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
rHuPH20
Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Celerion
Tempe, Arizona, United States
Countries
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Other Identifiers
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54767414EDI1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108356
Identifier Type: -
Identifier Source: org_study_id
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