Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-63733657 · 1 trial · 1 indication
An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
| Arm | Type | Description |
|---|---|---|
| SAD (Part 1): Healthy Subjects | EXPERIMENTAL | In Part 1, single ascending intravenous (IV) doses of JNJ-63733657 or placebo will be administered to sequential cohorts (Cohorts 1 to 5) of healthy subjects on Day 1. 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. Here, SAD indicates single ascending dose. |
| MAD (Part 2): Subjects With Alzheimer's Disease (AD) | EXPERIMENTAL | In Part 2, multiple ascending IV doses of JNJ-63733657 or placebo will be evaluated at three dose levels in sequential cohorts in subjects with prodromal or mild AD; 3 doses will be administered over a period of 8 weeks (Day 1, Day 29, Day 57). The starting dose will be decided based on the data from Part 1. Escalations will be done based on safety and tolerability similar to Part 1. Doses will not exceed those tested in Part 1. Here, MAD indicates multiple ascending dose. |
| Name | Type | Description |
|---|---|---|
| JNJ-63733657 | DRUG | Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously. |
| Placebo | DRUG | Subjects will receive matching placebo intravenously. |
Inclusion Criteria: General Inclusion Criteria: * Body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive (BMI = weight/height\^2) and body weight greater than 40 kilogram (kg) but less than 110 kg at screening * Women must not be of childbearing potential Specific ...
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JNJ-63733657 is an investigational small molecule developed by Johnson & Johnson for Alzheimer disease. It has completed a Phase 1 clinical trial in healthy subjects and subjects with Alzheimer's disease, and is not approved for any indication.
JNJ-63733657 is being studied for the treatment of Alzheimer disease. It is an investigational therapy and has not been approved for any use. The only completed trial enrolled healthy volunteers and subjects with Alzheimer's disease to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
JNJ-63733657 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is responsible for the clinical development of this small molecule for Alzheimer disease.
JNJ-63733657 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not received FDA approval.
JNJ-63733657 has been evaluated in one completed Phase 1 trial, NCT03375697, titled "A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease." The trial enrolled 72 participants across Belgium, Germany, the Netherlands, and Spain.