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Safety of GH001 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640831
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
GH Research Limited

Tracking Information
First Submitted Date  ICMJE November 12, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE March 13, 2019
Actual Primary Completion Date October 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • The safety and tolerability of GH001 [ Time Frame: up to 7 days ]
    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.
  • The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale [ Time Frame: Retrospectively assessed at 3 hours ]
    Visual Analogue Scale scored from 0-100
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of GH001 in Healthy Volunteers
Official Title  ICMJE A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Study Arms  ICMJE
  • Experimental: GH001 dose A
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: GH001 dose B
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: GH001 dose C
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: GH001 dose D
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
  • Experimental: GH001 Individualized Dosing
    Intervention: Drug: 5 Methoxy N,N Dimethyltryptamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2020)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 4, 2019
Actual Primary Completion Date October 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640831
Other Study ID Numbers  ICMJE GH001-HV-101
2018-003632-68 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GH Research Limited
Study Sponsor  ICMJE GH Research Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GH Research Clinical Team GH Research Limited
PRS Account GH Research Limited
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP