Safety and Pharmacokinetics of GH002 in Healthy Volunteers

GH Research

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05753956

GH002-HV-105

2022-002620-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 8 patient groups

Cohort A: Dose A single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort B: Dose B single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort C: Dose C single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort D: Dose D single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort E: Dose E single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort F: Dose F single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort G: Dose G single dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 5 Methoxy N,N Dimethyltryptamine

Cohort J: Individualized Dosing Regimen

Experimental group

Description:

Administration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part)

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine