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

NCT02758392 | Completed Phase 1

• 3 other identifiers: CR10816261178104NAP10012015-004253-40
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; JNJ-61178104; Placebo; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability

  Day 113

Secondary Outcomes (13)

• Serum Concentration of JNJ-61178104

  Up to Day 113

• JNJ-61178104 Antibodies Concentration

  Up to Day 113

• 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

• 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

Study Arms (6)

Dose 1: JNJ-61178104 OR Placebo IV

EXPERIMENTAL

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

Drug: JNJ-61178104 Intravenous; Drug: Placebo

Dose 2: JNJ-61178104 OR Placebo IV

EXPERIMENTAL

Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.

Drug: JNJ-61178104 Intravenous; Drug: Placebo

Dose 3: JNJ-61178104 OR Placebo IV

EXPERIMENTAL

Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.

Drug: JNJ-61178104 Intravenous; Drug: Placebo

Dose 4: JNJ-61178104 OR Placebo IV

EXPERIMENTAL

Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.

Drug: JNJ-61178104 Intravenous; Drug: Placebo

Dose 5: JNJ-61178104 OR Placebo IV

EXPERIMENTAL

Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.

Drug: JNJ-61178104 Intravenous; Drug: Placebo

Dose 6: JNJ-61178104 OR Placebo SC

EXPERIMENTAL

Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.

Drug: JNJ-61178104 Subcutaneous; Drug: Placebo

Interventions

JNJ-61178104 Intravenous DRUG

Participants will receive JNJ-61178104 Intravenously on Day 1.

Dose 1: JNJ-61178104 OR Placebo IV; Dose 2: JNJ-61178104 OR Placebo IV; Dose 3: JNJ-61178104 OR Placebo IV; Dose 4: JNJ-61178104 OR Placebo IV; Dose 5: JNJ-61178104 OR Placebo IV

JNJ-61178104 Subcutaneous DRUG

Participants will receive JNJ-61178104 Subcutaneously on Day 1.

Dose 6: JNJ-61178104 OR Placebo SC

Placebo DRUG

Participants will receive placebo on Day 1.

Dose 1: JNJ-61178104 OR Placebo IV; Dose 2: JNJ-61178104 OR Placebo IV; Dose 3: JNJ-61178104 OR Placebo IV; Dose 4: JNJ-61178104 OR Placebo IV; Dose 5: JNJ-61178104 OR Placebo IV; Dose 6: JNJ-61178104 OR Placebo SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
• Participant must have a body weight in the range of 50 Kilogram (kg) to 100 kg, inclusive, and have a body mass index of 19 Kilogram per meter square (kg/m\^2) to 30 kg/m2, inclusive
• Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day-1. If the results of the serum chemistry panel including liver enzymes, hematology panel, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's medical record with documented review confirmation by the investigator
• Before randomization, a woman must not be of childbearing potential: a) Postmenopausal {greater than (\>) 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 International Units Per Litre (IU/L) at Screening}; or b) Permanently sterilized (example, bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, oophorectomy); or c) Otherwise be incapable of pregnancy
• Be considered eligible according to the following tuberculosis (TB) Screening criteria: a) Have no history of latent or active TB prior to Screening; b) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) Have had no recent close contact with a person with active TB; d) Have a negative T-Spot TB test result at Screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

BE (1)