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

NCT03080987 | Completed Phase 1

• 3 other identifiers: CR1083062016-004785-2564179375EDI1002
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to Day 113

• Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to Day 113

Secondary Outcomes (19)

• Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375

  Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

• Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375

  Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

• Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375

  Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

• Part 1: Total Systemic Clearance (CL) of JNJ-64179375

  Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

• Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375

  Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

Study Arms (6)

Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.

Drug: JNJ-64179375 0.3 mg/kg; Other: Placebo

Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.

Drug: JNJ-64179375 1.0 mg/kg; Other: Placebo

Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.

Drug: JNJ-64179375 2.5 mg/kg; Other: Placebo

Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.

Other: Placebo; Drug: JNJ-64179375 (Dose to be Determined)

Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.

Other: Placebo; Drug: JNJ-64179375 (Dose to be Determined)

Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)

EXPERIMENTAL

Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1.

Drug: JNJ-64179375 1.0 mg/kg; Other: Placebo

Interventions

JNJ-64179375 0.3 mg/kg DRUG

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

Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)

JNJ-64179375 1.0 mg/kg DRUG

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

Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo); Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)

JNJ-64179375 2.5 mg/kg DRUG

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

Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)

Placebo OTHER

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

Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo); Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo); Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo); Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo); Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo); Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)

JNJ-64179375 (Dose to be Determined) DRUG

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

Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo); Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
• Body mass index (weight kg/m\^2) between 18 and 27 kilogram per square meter (kg/m\^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
• Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
• Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
• Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
• Clinically significant abnormal physical exam at Screening or Day -1
• Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
• Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Souseikai Hakata Clinic

Fukuoka, 812-0025, Japan

Location

Hammersmith Medicines Research Ltd

London, NW10 7EW, United Kingdom

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: March 10, 2017
• First Posted: March 15, 2017
• Study Start: June 27, 2017
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

GB (1); JP (1)