A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-61178104 Intravenous; Drug: JNJ-61178104 Subcutaneous; Drug: Placebo

• Registration Number: NCT02758392
• Lead Sponsor: Janssen Research & Development, LLC

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1: JNJ-61178104 OR Placebo IV	Placebo	Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
Dose 1: JNJ-61178104 OR Placebo IV	JNJ-61178104 Intravenous	Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
Dose 2: JNJ-61178104 OR Placebo IV	JNJ-61178104 Intravenous	Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
Dose 2: JNJ-61178104 OR Placebo IV	Placebo	Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
Dose 3: JNJ-61178104 OR Placebo IV	JNJ-61178104 Intravenous	Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
Dose 3: JNJ-61178104 OR Placebo IV	Placebo	Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
Dose 4: JNJ-61178104 OR Placebo IV	JNJ-61178104 Intravenous	Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
Dose 4: JNJ-61178104 OR Placebo IV	Placebo	Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
Dose 5: JNJ-61178104 OR Placebo IV	JNJ-61178104 Intravenous	Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
Dose 5: JNJ-61178104 OR Placebo IV	Placebo	Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
Dose 6: JNJ-61178104 OR Placebo SC	JNJ-61178104 Subcutaneous	Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.
Dose 6: JNJ-61178104 OR Placebo SC	Placebo	Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability	Day 113

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of JNJ-61178104	Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
JNJ-61178104 Antibodies Concentration	Up to Day 113
Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration	Up to Day 113
Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113	The F is the percentage of the subcutaneously administered dose that is systemically available relative to an intravenous (IV) administration. It is calculated as (AUC \[0-infinity\] for 1 mg/kg SC JNJ-61178104)/(AUC \[0-infinity\] for 1 mg/kg IV JNJ-61178104 )\*100, where the AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time.
Cytokine Concentrations	Predose, Up to Day 113
Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113
Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration	Up to Day 113
Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration	Up to Day 113