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NDX-1017 · 1 trial · 1 indication
Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.
| Arm | Type | Description |
|---|---|---|
| NDX-1017 | EXPERIMENTAL | NDX-1017 will be administered via subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered via subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| NDX-1017 | DRUG | Solution of NDX-1017 for subcutaneous injection |
| Placebo | DRUG | Placebo solution for subcutaneous injection |
INCLUSION CRITERIA: * Generally in good health * Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects) * Male subjects and their partners must be willing to comply with the contraceptive requirements o...
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NDX-1017 is an investigational small molecule being developed for the treatment of Alzheimer Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under study to evaluate its safety, tolerability, and pharmacokinetics in humans.
NDX-1017 is being developed by LeonaBio, Inc., a biopharmaceutical company traded under the ticker symbol LONA. The company is conducting clinical research on this investigational drug candidate for Alzheimer Disease.
NDX-1017 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for Alzheimer Disease.
NDX-1017 has one completed clinical trial, registered under NCT03298672, titled "Safety, Tolerability, and Pharmacokinetics Study of NDX-1017." This Phase 1 study enrolled 88 participants, including healthy volunteers, in the United States. The trial was randomized, double-blind, and placebo-controlled.
No, NDX-1017 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer Disease. The completed Phase 1 trial focused on safety, tolerability, and pharmacokinetics, but the drug has not yet received regulatory approval for any indication.