NCT04640831PHASE1COMPLETED

Safety of GH001 in Healthy Volunteers

A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers

Sponsor: GH Research Ireland Limited

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Request endpoint coverage

Key Facts

Study type

INTERVENTIONAL

Conditions

Healthy Volunteers

Interventions

5 Methoxy N,N Dimethyltryptamine

Enrollment

22 participants

Primary completion

Oct 2019

Study completion

Oct 2019

First posted

Nov 2020

Last updated

Aug 2023

Primary Endpoints (CT.gov)

The safety and tolerability of GH001

Time frame: up to 7 days

The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale

Time frame: Retrospectively assessed at 3 hours

Eligibility Criteria

Inclusion Criteria: * Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive); * Subject is in good general health in the opinion of the medical supervisor; * Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview; Exclusion Criteria: * Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT; * Has received any investigational medication within the last 1 month. * Has a medically significant condition, which renders the subject unsuitable for the study.

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Request coverage →

Source

Open on ClinicalTrials.gov