CompletedNCT03320707Updated Feb 3, 2025

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

A Phase 1 interventional study of Daratumumab and Placebo in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Aug 2019, 7 years 1 month ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 66 participants (actual)

Study arms

Experimental
Daratumumab
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 comparator
Placebo
Participants will receive placebo as a single SC dose in each of first 7 cohorts.
Drug: Placebo

Interventions

DrugDaratumumab
Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
Also known as: JNJ-54767414
DrugPlacebo
Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
DrugrHuPH20
Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Up to Day 141

Secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration.
Time frame: Day 1 predose through Day 141
Time to the Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time frame: 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])
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.
Time frame: 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])
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.
Time frame: Day 1 predose through Day 141
Number of Participants With Anti-daratumumab Antibodies
Number of participants who test positive for anti-daratumumab antibodies will be reported.
Time frame: Day 1 predose through Day 141
Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
Number of participants who test positive for anti-rHuPH20 antibodies will be reported.
Time frame: Day 1 predose through Day 141
Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry
The cluster of differentiation (CD) 38 expression levels and CD38 expressing cell counts, as measured by flow cytometry, will be summarized.
Time frame: Day 1 predose through Day 141

Study locations

1 site

Celerion
Tempe, Arizona 85283, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Aug 2019, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 11, 2017
First posted: Oct 25, 2017
StartActual: Oct 16, 2017
Primary completionActual: Aug 27, 2019
CompletionActual: Aug 27, 2019
Last update: Feb 3, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03320707
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Oct 25, 2017
Start date: Oct 16, 2017
Primary completion: Aug 27, 2019
Completion: Aug 27, 2019
Last update: Feb 3, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Daratumumab

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