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Safety of GH001 in Healthy Volunteers

NCT04640831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-15

No results posted yet for this study

Summary

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.

The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Conditions

  • Healthy Volunteers

Interventions

DRUG

5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

Sponsors & Collaborators

  • GH Research Ireland Limited

    lead INDUSTRY

Principal Investigators

  • GH Research Clinical Team · GH Research Ireland Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2019-10-04
Completion
2019-10-04

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640831 on ClinicalTrials.gov