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OpenTrials
Completed

NCT Number: NCT03320707

A 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daratumumab

Drug

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

Other names: JNJ-54767414

Placebo

Drug

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

rHuPH20

Drug

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

Primary outcomes

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

    Time frame: Up to Day 141

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

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

    Time frame: Up to Day 141

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

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 predose through Day 141

    Cmax is the maximum observed plasma concentration.

  2. Time to the Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day 1 predose through Day 141

    Tmax is defined as actual sampling time to reach maximum observed plasma concentration.

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

    Time frame: Day 1 predose through Day 141

    AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time corresponding to the last quantifiable serum concentration.

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

    Time frame: Day 1 predose through Day 141

    AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinity with extrapolation of the terminal phase, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  5. Number of Participants With Anti-daratumumab Antibodies

    Time frame: Day 1 predose through Day 141

    Number of participants who test positive for anti-daratumumab antibodies will be reported.

  6. Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies

    Time frame: Day 1 predose through Day 141

    Number of participants who test positive for anti-rHuPH20 antibodies will be reported.

  7. Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry

    Time frame: Day 1 predose through Day 141

    The cluster of differentiation (CD) 38 expression levels and CD38 expressing cell counts, as measured by flow cytometry, will be summarized.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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