A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT03320707
Run by: Janssen Research & Development, LLC
People needed: 66
Starts: 2017-10-16
Expected to finish: 2019-08-27
Last updated by the study team: 2025-02-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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