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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: JNJ-64179375 1.0 mg/kg; Drug: JNJ-64179375 2.5 mg/kg; Drug: JNJ-64179375 0.3 mg/kg; Drug: JNJ-64179375 (Dose to be Determined)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03080987

64179375EDI1002 (Other Identifier)

2016-004785-25 (EudraCT Number)

CR108306

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 6 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64179375 0.3 mg/kg

Other: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64179375 1.0 mg/kg

Other: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64179375 2.5 mg/kg

Other: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64179375 (Dose to be Determined)

Other: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64179375 (Dose to be Determined)

Other: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64179375 1.0 mg/kg

Other: Placebo