Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CEL383 · 1 trial · 1 indication
Incidence of TEAEs by type, severity, seriousness, and relationship
| Arm | Type | Description |
|---|---|---|
| CEL383 Arm | EXPERIMENTAL | Subjects will receive a single intravenous dose of CEL383 |
| Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive a single intravenous dose of placebo |
| Name | Type | Description |
|---|---|---|
| CEL383 | DRUG | Subjects will receive CEL383 |
| Placebo | DRUG | Subjects will receive placebo |
Inclusion Criteria: * Healthy, adult, male or female (of nonchildbearing potential only), 19-64 years of age, inclusive, at screening visit * Willingness of men of reproductive potential to agree to use a condom with spermicide or abstain from heterosexual intercourse from dosing until at least 90 ...
CEL383 is an investigational small molecule being developed by cbdMD, Inc. (ticker: YCBD). It is currently in Phase 1 clinical development. The drug is being studied in healthy adult subjects, and its therapeutic area is classified as Other.
CEL383 is being studied for use in healthy adult subjects. It is currently in Phase 1 clinical development, with a completed first-in-human trial. The drug is not approved for any indication and remains investigational.
CEL383 is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy subjects.
CEL383 is in Phase 1 clinical development. A first-in-human, single ascending dose study has been completed. The drug is investigational and has not been approved by regulatory authorities.
CEL383 has one completed Phase 1 clinical trial, identified as NCT05901883. This was a first-in-human, single ascending dose study in 48 healthy adult subjects in the United States. The trial was randomized, double-blind, and placebo-controlled.
CEL383 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A first-in-human study has been completed, but the drug remains under clinical investigation and has not received regulatory approval.