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MELT-100

Phase 1

Healthy Volunteers | Small molecule | Other |Harrow, Inc.|Last Updated: Feb 23, 2021

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical trial landscape

MELT-100 · 1 trial · 1 indication

Phase 1 1
NCT04485702Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or KetamineHealthy Volunteers
COMPLETED17 Analytics
PHASE1COMPLETED
Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine
Healthy Volunteers
NCT0448570217
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Study Endpoints
Primary Endpoints
Peak Plasma Concentration (Cmax)
24 hours
Area under the plasma concentration versus time curve (AUC)
24 hours
Time to peak plasma concentration (Tmax)
24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
MELT-100ACTIVE_COMPARATOR3mg midazolam and 25mg ketamine sublingual tablet
IV midazolamACTIVE_COMPARATOR2mg Intravenous midazolam
IV ketamineACTIVE_COMPARATOR6mg Intravenous ketamine
Interventions
NameTypeDescription
Midazolam injectionDRUG2mg IV
Ketamine Injectable ProductDRUG6mg IV
MELT-100DRUGmidazolam 3mg and ketamine 25mg SL tablet
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Eligibility Criteria
Age Range55 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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