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JNJ-63733657 · 3 trials · 2 indications
Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
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.
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 |
|---|---|---|
| JNJ-63733657 | EXPERIMENTAL | Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1. |
| Cohort 1: JNJ-63733657 or Placebo | EXPERIMENTAL | Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo. |
| Cohort 2: JNJ-63733657 or Placebo | EXPERIMENTAL | Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo. |
| Cohort 3: JNJ-63733657 or Placebo | EXPERIMENTAL | Participants will receive a single IV high dose of JNJ-63733657 or matching placebo. |
| 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 | JNJ-63733657 will be administered as an IV infusion. |
| Placebo | DRUG | Participants will receive matching placebo intravenously. |
Inclusion Criteria: * Healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded...
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JNJ-63733657 is an investigational small molecule being studied for Alzheimer's disease and in healthy participants. It is in Phase 1 clinical development, with completed trials in healthy subjects and subjects with Alzheimer's disease. The drug is not approved and remains under investigation.
JNJ-63733657 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting Phase 1 clinical trials for this investigational small molecule in Alzheimer's disease and healthy participants.
JNJ-63733657 is in Phase 1 clinical development. It has completed two Phase 1 trials, including studies in healthy subjects and subjects with Alzheimer's disease. The drug is investigational and has not been approved by regulatory authorities.
JNJ-63733657 has completed three Phase 1 trials. NCT03375697 studied safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and subjects with Alzheimer's disease across Belgium, Germany, Netherlands, and Spain. NCT03689153 studied healthy Japanese participants, and NCT05407818 studied healthy Chinese participants.
JNJ-63733657 is the only name provided for this investigational drug. No alternative names have been reported. It is a small molecule being studied for Alzheimer's disease and in healthy participants, developed by Johnson & Johnson.