DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.

Summary

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

DRUG

IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1

DRUG

IHL-42X: 5 mg dronabinol + 125 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2

DRUG

IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3

DRUG

IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4

DRUG

IHL-42X: 5 mg dronabinol + 250 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5

DRUG

IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6

DRUG

IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7

DRUG

IHL-42X: 5 mg dronabinol + 375 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8

DRUG

IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide

DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9

DRUG

Placebo: Negative control

DReAMzz Phase 2 Placebo

Sponsors & Collaborators

• Incannex Healthcare Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-21

Primary Completion

2027-04-30

Completion

2027-05-31

FDA Drug

Yes

Countries

• United States

Study Locations