A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/16/2018 |
| Start Date: | October 16, 2017 |
| End Date: | June 17, 2019 |
| Contact: | Study Contact |
| Email: | JNJ.CT@sylogent.com |
| Phone: | 844-434-4210 |
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
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.
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.
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
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