Safety of GH001 in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT04640831
• Recruitment Status: Completed
• First Posted: November 23, 2020
• Last Update Posted: November 23, 2020
• Sponsor: GH Research Ireland Limited
• Information provided by (Responsible Party): GH Research Ireland Limited

Tracking Information

• First Submitted Date: November 12, 2020
• First Posted Date: November 23, 2020
• Last Update Posted Date: November 23, 2020
• Actual Study Start Date: March 13, 2019
• Actual Primary Completion Date: October 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety of GH001 in Healthy Volunteers
• Official Title: 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: Interventional
• Study Phase: Phase 1

Study Design

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: Healthy Volunteers

Intervention

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

Other Names:

• GH001
• 5-MeO-DMT

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 18, 2020): 22
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 4, 2019
• Actual Primary Completion Date: October 4, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT04640831
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: GH Research Ireland Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: GH Research Ireland Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GH Research Clinical Team; GH Research Ireland Limited

• PRS Account: GH Research Ireland Limited
• Verification Date: November 2020