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A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

NCT02609789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).

Conditions

Interventions

DRUG

JNJ-55920839

JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.

DRUG

Placebo

0.9 percent (%) normal saline.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Moldova
  • Poland
  • Romania
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609789 on ClinicalTrials.gov