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| ID | Type | Description | Link |
|---|---|---|---|
| 63733657EDI1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-63733657 or Placebo | Experimental | Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo. |
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| Cohort 2: JNJ-63733657 or Placebo | Experimental | Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo. |
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| Cohort 3: JNJ-63733657 or Placebo | Experimental | Participants will receive a single IV high dose of JNJ-63733657 or matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of JNJ-63733657 | The Cmax is the maximum observed serum concentration. | Up to Day 106 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan |
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| Placebo | Drug | Participants will receive matching placebo intravenously. |
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The Tmax is defined as actual sampling time to reach maximum observed serum concentration.
| Up to Day 106 |
| Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days]) | The AUC (0-56days) is the area under the serum concentration versus time curve from time 0 to time to 56 days after the start of infusion. | 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]) | The AUC (0-last) is the area under the serum concentration-time curve from time zero time to the time corresponding to the last quantifiable serum concentration. | Up to Day 106 |
| Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) | The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed measurable serum concentration, and lambda(z) is elimination rate constant. | Up to Day 106 |
| Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum | Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. | Up to Day 106 |
| Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum | The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Up to Day 106 |
| Total Systemic Clearance (CL) of JNJ-63733657 in Serum | Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum area under the plasma concentration-time curve from time zero to infinite time (AUC[0-infinity]). | Up to Day 106 |
| Volume of Distribution (Vz) of JNJ-63733657 in Serum | The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Up to Day 106 |
| JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF) | CSF concentration assessments will be done for JNJ-63733657. | Up to Day 92 |
| Number of Participants with Anti-JNJ-63733657 Antibodies | Number of participants with anti-JNJ-63733657 antibodies will be determined in serum samples. | Up to Day 106 |
| Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF | Percentage change from baseline in total, free, and bound tau (phosphorylation site) biomarker fragments in CSF will be evaluated to assess the effect of JNJ-63733657. | Up to Day 92 |