A Study of JNJ-63733657 in Healthy Japanese Participants

NCT03689153 | Completed Phase 1

• 2 other identifiers: CR10852263733657EDI1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy Japanese participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An AE 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.

  Approximately 23 weeks

Secondary Outcomes (12)

• Maximum Observed Serum Concentration (Cmax) of JNJ-63733657

  Up to Day 106

• Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657

  Up to Day 106

• Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days])

  0 hours (Day 1) up to 56 days

• Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last])

  Up to Day 106

• Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity])

  Up to Day 106

Study Arms (3)

Cohort 1: JNJ-63733657 or Placebo

EXPERIMENTAL

Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.

Drug: JNJ-63733657; Drug: Placebo

Cohort 2: JNJ-63733657 or Placebo

EXPERIMENTAL

Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.

Drug: JNJ-63733657; Drug: Placebo

Cohort 3: JNJ-63733657 or Placebo

EXPERIMENTAL

Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.

Drug: JNJ-63733657; Drug: Placebo

Interventions

JNJ-63733657 DRUG

Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.

Cohort 1: JNJ-63733657 or Placebo; Cohort 2: JNJ-63733657 or Placebo; Cohort 3: JNJ-63733657 or Placebo

Placebo DRUG

Participants will receive matching placebo intravenously.

Cohort 1: JNJ-63733657 or Placebo; Cohort 2: JNJ-63733657 or Placebo; Cohort 3: JNJ-63733657 or Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI; weight \[kilogram {kg}\]/height \[meter square {m\^2}\]) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, and a body weight greater than 50 kg but less than 110 kg at screening and Day -1. For participants to be enrolled in the highest dose cohort (Cohort 3), additional weight limitations will apply in order not to exceed the total dose of 5 gram (g) JNJ-63733657; the participant weight in the highest dose cohort will be limited
• Women must not be of childbearing potential

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, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening and Day -1 in the opinion of the investigator
• Clinically significant abnormal physical or neurologic examination (including fundoscopy), vital signs, or 12-lead electrocardiogram (ECG) at screening and Day -1 in the opinion of the investigator
• Positive result on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody (antiHCV) positive, or any other clinically active liver disease at screening (per screening evaluations)
• History of human immunodeficiency virus (HIV) antibody positive, tests positive for HIV or tests positive for syphilis at screening
• Mini-Mental State Examination (MMSE) score less than or equal to (\<=) 27 at screening

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: September 28, 2018
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

JP (1)