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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

NCT03080987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-03

No results posted yet for this study

Summary

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

Conditions

  • Healthy

Interventions

DRUG

JNJ-64179375 0.3 mg/kg

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.

DRUG

JNJ-64179375 1.0 mg/kg

JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

DRUG

JNJ-64179375 2.5 mg/kg

JNJ-64179375 2.5 mg/kg IV infusion on Day 1.

OTHER

Placebo

Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

DRUG

JNJ-64179375 (Dose to be Determined)

JNJ-64179375 IV infusion (Dose to be determined).

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
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2018-06-25
Completion
2018-06-25

Countries

  • Japan
  • United Kingdom

Study Locations

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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 NCT03080987 on ClinicalTrials.gov