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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06511947 | Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects | PHASE1 | RECRUITING | 52 | — | — | Aug 1, 2024 | Feb 1, 2025 | Aug 7, 2024 | 1 | United Kingdom |
| NCT05753956 | Safety and Pharmacokinetics of GH002 in Healthy Volunteers | PHASE1 | COMPLETED | 64 | — | — | Dec 22, 2022 | Nov 29, 2023 | Jan 25, 2024 | 1 | Netherlands |
| NCT05163691 | Pharmacokinetics of GH001 in Healthy Volunteers | PHASE1 | COMPLETED | 46 | — | — | Jun 21, 2021 | Nov 22, 2021 | Dec 20, 2021 | 1 | Netherlands |
| NCT04640831 | Safety of GH001 in Healthy Volunteers | PHASE1 | COMPLETED | 22 | — | — | Mar 13, 2019 | Oct 4, 2019 | Aug 15, 2023 | 1 | Netherlands |
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Adverse events reported in the study and coded by MedDRA.
Percentage of subjects with clinically significant changes\* from baseline in ECG (heart rate, RR, QT, PR, and QRS intervals, and QTcF). Percentage of subjects with clinically significant changes\* from baseline in vital signs (systolic and diastolic blood pressure, respiration rate, heart rate, peripheral oxygen saturation, body temperature). Percentage of subjects with clinically significant changes\* from baseline in spirometry (forced expiratory volume in 1 second \[FEV1\] and forced vital capacity \[FVC\]). Percentage of subjects with clinically significant changes\* from baseline in safety laboratory assessments (hematology, biochemistry, and urinalysis). \*Clinically significant changes as determined by the principal investigator
The MOAA/S will be completed before and after GH001 dosing. Scored from 0 (deep sedation) to 5 (alert).
The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76.
Assessment of Discharge Readiness on the administration day by the principal investigator, using the Clinical Assessment of Discharge Readiness (CADR).
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126 and a higher score means a worse outcome.
Adverse events reported in the study and coded by MedDRA.
Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.
For PK analyses, blood samples will be collected before and up to 4 hours after the administration of GH001 to determine 5-MeO-DMT and bufotenine serum concentrations.
The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses.
Visual Analogue Scale scored from 0-100
| Arm | Type | Description |
|---|---|---|
| Part 1, Cohort A | EXPERIMENTAL | A single dose inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort B | EXPERIMENTAL | A single dose inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort C | EXPERIMENTAL | A single dose inhaled dose of 18 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort D (optional) | EXPERIMENTAL | A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on study safety group \[SSG\] review of PK, PD and safety data from Cohorts A, B, and C). |
| Part 1, Cohort E (optional) | EXPERIMENTAL | A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on SSG review of PK, PD and safety data from Cohorts A, B, and C). |
| Part 2, Cohort F | EXPERIMENTAL | Up to three escalating inhaled doses of GH001 (doses as determined by Part 1, maximum single inhaled dose of 18 mg) administered via a proprietary aerosol delivery device in 12 subjects. |
| Cohort A: Dose A single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort B: Dose B single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort C: Dose C single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort D: Dose D single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort E: Dose E single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort F: Dose F single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort G: Dose G single dose | EXPERIMENTAL | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort J: Individualized Dosing Regimen | EXPERIMENTAL | Administration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part) |
| Group A - 6 mg single-dose | EXPERIMENTAL | A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group B - 12 mg single-dose | EXPERIMENTAL | A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group C - 18 mg single-dose | EXPERIMENTAL | A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group D - Individualized Dosing Regimen, 1-hour interval | EXPERIMENTAL | Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 1-hour dose interval (8 subjects) |
| Group E - Individualized Dosing Regimen, 2-hour interval | EXPERIMENTAL | Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 2-hour dose interval (8 subjects) |
| GH001 dose A | EXPERIMENTAL | - |
| GH001 dose B | EXPERIMENTAL | - |
| GH001 dose C | EXPERIMENTAL | - |
| GH001 dose D | EXPERIMENTAL | - |
| GH001 Individualized Dosing | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 5 Methoxy N,N Dimethyltryptamine | DRUG | GH001 administered via inhalation |
| Placebo | DRUG | GH002 placebo administered via i.v. bolus injection |
Inclusion Criteria: * Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening * Good mental health in the opinion of the investigator. * Normal spirometry (FEV1 of \>80% of predicted and FVC of \>80% of predicted value) at screening. Exclusion Criteria: * Has known allergi...