Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05282797 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test | PHASE2 | COMPLETED | 154 | — | — | Dec 15, 2021 | Aug 26, 2023 | Aug 29, 2023 | 1 | Netherlands |
Feeling High on a visual analog scale (mm)
Body sway (mm);
Alertness on a visual analog scale (mm)
Heart Rate in beats/min
| Arm | Type | Description |
|---|---|---|
| Part A - ANEB-001 | EXPERIMENTAL | Subjects receive THC and varying amounts of ANEB-001 |
| Part A - Placebo | PLACEBO_COMPARATOR | Subjects receive THC and placebo |
| Part B - Cohort 1 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 30 mg of ANEB-001 |
| Part B - Cohort 1 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg of THC and placebo |
| Part B - Cohort 2 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 10 mg of ANEB-001 |
| Part B - Cohort 2 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg of THC and placebo |
| Part B - Cohort 3 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001 |
| Part B - Cohort 3 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg THC and 1 hour later, placebo |
| Part B - Cohort 4 - ANEB-001 | EXPERIMENTAL | Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 4 - Placebo | PLACEBO_COMPARATOR | Subjects receive 40 mg of THC and 1 hour later, placebo |
| Part B - Cohort 5 - ANEB-001 | EXPERIMENTAL | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 5 - Placebo | PLACEBO_COMPARATOR | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 6 - ANEB-001 | EXPERIMENTAL | Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 6 - Placebo | PLACEBO_COMPARATOR | Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo |
| Part C - Cohort 7 - ANEB-001 | EXPERIMENTAL | Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001 |
| Part C - Cohort 8 - ANEB-001 | EXPERIMENTAL | Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001 |
| Name | Type | Description |
|---|---|---|
| ANEB-001 | DRUG | Experimental Treatment |
| Placebo | DRUG | Placebo comparator |
Inclusion Criteria: * Signed informed consent prior to any study-mandated procedure * BMI between 18 and 30 kg/m2 * Minimum weight 50 kg * Occasional cannabis user Exclusion Criteria: * Evidence of active or chronic condition that could interfere with, or which the treatment of might interfere wi...