Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-11-29

Brief Summary

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The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will include separate single and multiple-dose parts.

Single-dose Part:

A double-blind, placebo-controlled, randomized, dose escalation design with single doses of GH002 delivered by i.v. bolus injection in 7 consecutive cohorts with 8 subjects per cohort (randomized as 6 active and 2 placebo):

Cohort A: Dose A

Cohort B: Dose B

Cohort C: Dose C

Cohort D: Dose D

Cohort E: Dose E

Cohort F: Dose F

Cohort G: Dose G

Up to 2 additional cohorts may be added before the IDR part is initiated. These will be named cohorts H and I, if needed.

Multiple-Dose Part:

An open-label, non-randomized design with up to 3 doses of GH002 administered to subjects by i.v. bolus injection(s) on a single day in one cohort of 8 subjects:

Cohort J: Individualized Dosing Regimen with GH002.

The exact doses of study drug to be administered will be determined after an unblinded review of the safety, PK and PD data from all of the cohorts in the single dose part of the trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort A: Dose A single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort B: Dose B single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort C: Dose C single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort D: Dose D single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort E: Dose E single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort F: Dose F single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort G: Dose G single dose

A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Placebo

Intervention Type DRUG

GH002 placebo administered via i.v. bolus injection

Cohort J: Individualized Dosing Regimen

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 Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH002 administered via i.v. bolus injection(s)

Interventions

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5 Methoxy N,N Dimethyltryptamine

GH002 administered via i.v. bolus injection(s)

Intervention Type DRUG

Placebo

GH002 placebo administered via i.v. bolus injection

Intervention Type DRUG

Other Intervention Names

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GH002 5-MeO-DMT GH002 placebo

Eligibility Criteria

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Inclusion Criteria

* Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
* Is deemed in good physical health by the investigator.
* Is in good mental health in the opinion of the investigator and clinical psychologist

Exclusion Criteria

* Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
* Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes