Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5 Methoxy N, N Dimethyltryptamine · 6 trials · 5 indications
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.
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Incidence of adverse events reported in the study and coded by MedDRA.
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.
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.
Phase 1: The primary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.
Phase 2: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.
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 |
|---|---|---|
| GH001 | EXPERIMENTAL | A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects |
| 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) |
| Phase 1 (Part A): GH001 dose A | EXPERIMENTAL | - |
| Phase 1 (Part A): GH001 dose B | EXPERIMENTAL | - |
| Phase 2 (Part B): GH001 Individualized Dosing Regimen | EXPERIMENTAL | - |
| 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 |
| GH001 Aerosol Delivery System | DEVICE | GH001 aerosol delivery system |
| 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 allerg...
5 Methoxy N,N Dimethyltryptamine is being investigated for use in treatment resistant depression, as well as in healthy adults and healthy volunteers for research purposes. It is currently in Phase 1 clinical development as a small molecule therapeutic.
5 Methoxy N,N Dimethyltryptamine is being developed by GH Research PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol GHRS. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug.
5 Methoxy N,N Dimethyltryptamine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing and completed trials are focused on healthy volunteers to assess safety, tolerability, and pharmacokinetics.
5 Methoxy N,N Dimethyltryptamine has been studied in several Phase 1 trials. Completed trials include NCT04640831, NCT05163691, and NCT05753956, which evaluated safety and pharmacokinetics in healthy volunteers in the Netherlands. An additional trial, NCT06511947, is investigating delivery via a proprietary aerosol device in healthy subjects in the United Kingdom.
5 Methoxy N,N Dimethyltryptamine is referred to as GH001 in clinical trial records. The trials NCT04640831, NCT05163691, and NCT06511947 specifically study GH001, while NCT05753956 studies GH002, which may be a related compound. The drug is also known by the abbreviation 5-MeO-DMT.