- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05753956
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
January 24, 2024 updated by: GH Research Ireland Limited
A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002.
As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: GH Research Limited Clinical Trial Enquiries
- Phone Number: +353 87 450 3237
- Email: clinicaltrials@ghres.com
Study Locations
-
-
-
Groningen, Netherlands
- GH Research Clinical Trial Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
- Is deemed in good physical health by the investigator.
- Is in good mental health in the opinion of the investigator and clinical psychologist
Exclusion Criteria:
- Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
- Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
- Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A: Dose A single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort B: Dose B single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort C: Dose C single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort D: Dose D single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort E: Dose E single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort F: Dose F single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort G: Dose G single dose
A single dose of GH002 or placebo administered by i.v.
bolus injection (randomized as 6 active and 2 placebo subjects)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
GH002 placebo administered via i.v.
bolus injection
Other Names:
|
Experimental: Cohort J: Individualized Dosing Regimen
Administration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part)
|
GH002 administered via i.v.
bolus injection(s)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability: incidence of treatment emergent adverse events
Time Frame: Up to 7 days
|
Adverse events reported in the study and coded by MedDRA.
|
Up to 7 days
|
Safety and tolerability: local tolerance (injection site reactions)
Time Frame: Up to discharge on dosing day
|
Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.
|
Up to discharge on dosing day
|
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
Time Frame: Up to 7 days
|
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
|
Up to 7 days
|
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
Time Frame: Up to discharge on dosing day
|
The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH002 dosing.
Scored from 0 (deep sedation) to 5 (alert)
|
Up to discharge on dosing day
|
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Time Frame: Up to 7 days
|
The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely.
Summed together, these subscales form a total dissociative score.
Combined score ranges from 0 to 76
|
Up to 7 days
|
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
Time Frame: Up to discharge on dosing day
|
Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).
|
Up to discharge on dosing day
|
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
Time Frame: Up to 7 days
|
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
|
Up to 7 days
|
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Time Frame: Up to 7 days
|
A scale to measure psychiatric symptoms.
Each symptom is rated 1-7 and a total of 18 symptoms are scored.
Combined score ranges from 18 to 126.
|
Up to 7 days
|
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
Time Frame: Up to 6 hours
|
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.
|
Up to 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic assessment: The dose-related psychoactive effects of GH002 as evaluated by a Visual Analogue Scale
Time Frame: Up to 1 hour after dosing
|
The Peak Experience Scale (PES) is a Visual Analogue Scale scored from 0-100
|
Up to 1 hour after dosing
|
Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
Time Frame: Up to 1 hour after dosing
|
Completed by the subject after GH002 administration and assesses seven factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) all scored from 0 to 5.
|
Up to 1 hour after dosing
|
Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
Time Frame: Up to 1 hour after dosing
|
The MEQ30 is a validated procedure for assessing the extent of the psychoactive effects experienced by a subject.
The validated MEQ30 uses thirty assessment questions across four areas of experience, all scored from 0 to 5.
|
Up to 1 hour after dosing
|
Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
Time Frame: Up to 1 hour after dosing
|
The duration of the experience, defined as time in minutes from drug administration to time when the subject reports that any psychoactive symptoms have subsided will be recorded.
|
Up to 1 hour after dosing
|
PK/PD relationship(s) of 5-MeO-DMT
Time Frame: Up to 1 hour after dosing
|
In particular the correlation between Cmax and AUC with PES score and duration of PsE as scored by the investigator will be described
|
Up to 1 hour after dosing
|
Cognitive Function: Change from baseline in Rapid visual information processing (RVP) test
Time Frame: Up to 7 days
|
A computerized test assessing the reaction time in response to a visual stimulus.
|
Up to 7 days
|
Cognitive Function: Change from baseline in Verbal recognition memory (VRM) test
Time Frame: Up to 7 days
|
The VRM test is based on successive auditory presentations of 18-word lists followed by attempted recall.
|
Up to 7 days
|
Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
Time Frame: Up to 7 days
|
The SWM test requires retention and manipulation of visuospatial information.
This test has notable executive function demands, and measures strategy use as well as errors.
In this task the subject has to search for tokens hidden in boxes on screen.
The subject must touch a box to open the box to reveal either a yellow token or an empty box.
Once the subject has found a yellow token, they must touch the outline of the right-hand side of the screen to 'store' it.
The subject must then continue searching through the boxes until all of the tokens have been found.
The test takes about 4 minutes to complete
|
Up to 7 days
|
Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
Time Frame: Up to 7 days
|
The DSST is a global measure of cognitive ability, requiring the engagement of multiple cognitive domains in order to complete effectively.
A computerized test with the task is to match digits with symbols from encoding list.
The number of digits correctly encoded within 90 seconds is the performance measure.
|
Up to 7 days
|
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of bufotenine
Time Frame: Up to 6 hours
|
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine bufotenine serum concentrations.
|
Up to 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2022
Primary Completion (Actual)
November 29, 2023
Study Completion (Actual)
November 29, 2023
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
March 3, 2023
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH002-HV-105
- 2022-002620-13 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on 5 Methoxy N,N Dimethyltryptamine
-
GH Research Ireland LimitedCompletedDepression | Major Depressive Disorder | Treatment Resistant DepressionNetherlands
-
GH Research Ireland LimitedCompleted
-
GH Research Ireland LimitedRecruitingTreatment-resistant DepressionIreland, Czechia
-
GH Research Ireland LimitedRecruiting
-
GH Research Ireland LimitedCompleted
-
GH Research Ireland LimitedRecruitingPostpartum Depression | Postnatal DepressionUnited Kingdom, Netherlands
-
University Hospital, Basel, SwitzerlandNot yet recruiting
-
University Hospital, Basel, SwitzerlandCompleted
-
Usona InstituteCompletedPharmacokinetics | Tolerability | SafetyUnited States
-
Small Pharma LtdCompleted