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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rHuPH20; Drug: Placebo; Drug: Daratumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320707

CR108356

54767414EDI1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Daratumumab

Experimental group

Description:

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).

Treatment:

Drug: Daratumumab

Drug: rHuPH20

Placebo

Placebo Comparator group

Description:

Participants will receive placebo as a single SC dose in each of first 7 cohorts.

Treatment:

Drug: Placebo