Incannex Healthcare Ltd
The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.
Inclusion Criteria Participants must satisfy all the following criteria at screening unless otherwise stated: 1. Aged ≥18 and ≤65 years of age at the time of consent. 2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria: 1. AHI4 ≥5 2. ≤25% central or mixed apneas out of total AHI 3. no Cheyne-Stokes respiration 4. total sleep time ≥ 4 hours in each PSG 5. \< 30 periodic leg movement disorder arousals per hour. 3. A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2. 4. A PROMIS-SRI 8a score of \>16. 5. Intolera…
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
DReAMzz Phase 2 Placebo