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

NCT03320707 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10835654767414EDI1001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo

  The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.

  Up to Day 141

• Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo

  The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.

  Up to Day 141

Secondary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 predose through Day 141

• Time to the Maximum Observed Plasma Concentration (Tmax)

  Day 1 predose through Day 141

• Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last])

  Day 1 predose through Day 141

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity])

  Day 1 predose through Day 141

• Number of Participants With Anti-daratumumab Antibodies

  Day 1 predose through Day 141

Study Arms (2)

Daratumumab

EXPERIMENTAL

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).

Drug: Daratumumab; Drug: rHuPH20

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Daratumumab DRUG

Single SC dose of daratumumab will be administered in each of 8 dose cohorts.

Also known as: JNJ-54767414

Daratumumab

Placebo DRUG

Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.

Placebo

rHuPH20 DRUG

Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.

Daratumumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

daratumumab

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 25, 2017
• Study Start: October 16, 2017
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)