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MELT-100 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MELT-100 | ACTIVE_COMPARATOR | 3mg midazolam and 25mg ketamine sublingual tablet |
| IV midazolam | ACTIVE_COMPARATOR | 2mg Intravenous midazolam |
| IV ketamine | ACTIVE_COMPARATOR | 6mg Intravenous ketamine |
| Name | Type | Description |
|---|---|---|
| Midazolam injection | DRUG | 2mg IV |
| Ketamine Injectable Product | DRUG | 6mg IV |
| MELT-100 | DRUG | midazolam 3mg and ketamine 25mg SL tablet |
Inclusion Criteria: * A subject must satisfy all of the following criteria to be eligible for study participation: 1. Able to understand and voluntarily consent to participation in this study, and provides written informed consent before the start of any study-specific procedures. 2. Healthy a...
MELT-100 is an investigational small molecule therapeutic being developed by Harrow, Inc. It is a sublingual formulation studied in a Phase 1 bioavailability trial in healthy volunteers. Its specific therapeutic indications have not been publicly disclosed, and it remains in clinical development.
MELT-100 is being developed by Harrow, Inc., which trades on the Nasdaq under the ticker HROW. Harrow is the sponsor of the clinical program for this asset.
MELT-100 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA.
MELT-100 has been evaluated in one completed Phase 1 trial, NCT04485702, titled a Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine. The trial enrolled 17 healthy volunteers in the United States, was randomized and active-controlled, and included participants aged 55 years and older.
MELT-100 is an investigational product whose intended therapeutic indications have not been publicly disclosed. Its only reported clinical study was conducted in healthy volunteers rather than in a patient population, so no approved or established use has been announced for MELT-100.