A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Interventional Study of JNJ-61178104 in Healthy Subjects

Janssen Research & Development, LLC0 sites54 target enrollmentApril 2016

ConditionsHealthy

InterventionsJNJ-61178104 Intravenous Placebo JNJ-61178104 Subcutaneous

DrugsJNJ-61178104 Intravenous JNJ-61178104 Subcutaneous Placebo

Overview

Phase: Phase 1
Intervention: JNJ-61178104 Intravenous
Conditions: Healthy
Sponsor: Janssen Research & Development, LLC
Enrollment: 54
Primary Endpoint: Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants.

Detailed Description

This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

January 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Participant currently has or has a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, cardiac, vascular, metabolic, endocrine, rheumatologic, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
•Participant has a QT corrected according to Fridericia's formula (QTcF) interval \>450 msec, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome) at Screening and at Day -1
•Participant has had major surgery, (example, requiring general anesthesia) within 4 months before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 17 weeks after the last dose of study drug administration
•Participant plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through the end of the study
•Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-61178104 and its excipients used in this study

Arms & Interventions

Dose 1: JNJ-61178104 OR Placebo IV

Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.