A Study of JNJ-63733657 in Healthy Japanese Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-63733657; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03689153

63733657EDI1002 (Other Identifier)

CR108522

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort 1: JNJ-63733657 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: JNJ-63733657

Cohort 2: JNJ-63733657 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: JNJ-63733657

Cohort 3: JNJ-63733657 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: JNJ-63733657