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NCT03320707 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target
1
Study location

NCT03320707 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 66 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03320707, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target
1
Study location

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

Interventions

  • DRUG Placebo
  • DRUG Daratumumab
  • DRUG rHuPH20

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2017-10-16
Est. Completion 2019-08-27
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT03320707

The ClinicalTrials.gov registry entry for NCT03320707 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03320707 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT03320707 about?

NCT03320707 is a clinical study titled "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 hea...

What is the current status of trial NCT03320707?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2017-10-16. Estimated completion is 2019-08-27.

What conditions does trial NCT03320707 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT03320707?

The interventions under investigation include: Placebo (DRUG), Daratumumab (DRUG), rHuPH20 (DRUG).

Who is sponsoring clinical trial NCT03320707?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03320707 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.