Safety of GH001 in Healthy Volunteers
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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
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Sponsor:
GH Research Ireland Limited
Information provided by (Responsible Party):
GH Research Ireland Limited
Tracking Information | |||||
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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 |
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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. |
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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 |
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Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE | Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | GH Research Ireland Limited | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | GH Research Ireland Limited | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GH Research Ireland Limited | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |