Clinical trial NCT05753956: Safety and Pharmacokinetics of GH002 in Healthy Volunteers
Official title: A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: 5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine
Healthy Volunteers
Pharmacokinetics
Mebufotenin
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2023-03-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will include separate single and multiple-dose parts.

Single-dose Part:

A double-blind, placebo-controlled, randomized, dose escalation design with single doses of GH002 delivered by i.v. bolus injection in 7 consecutive cohorts with 8 subjects per cohort (randomized as 6 active and 2 placebo):

Cohort A: Dose A

Cohort B: Dose B

Cohort C: Dose C

Cohort D: Dose D

Cohort E: Dose E

Cohort F: Dose F

Cohort G: Dose G

Up to 2 additional cohorts may be added before the IDR part is initiated. These will be named cohorts H and I, if needed.

Multiple-Dose Part:

An open-label, non-randomized design with up to 3 doses of GH002 administered to subjects by i.v. bolus injection(s) on a single day in one cohort of 8 subjects:

Cohort J: Individualized Dosing Regimen with GH002.

The exact doses of study drug to be administered will be determined after an unblinded review of the safety, PK and PD data from all of the cohorts in the single dose part of the trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability: incidence of treatment emergent adverse events
timeFrame: Up to 7 days
measure: Safety and tolerability: local tolerance (injection site reactions)
timeFrame: Up to discharge on dosing day
measure: Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
timeFrame: Up to 7 days
measure: 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
timeFrame: Up to discharge on dosing day
measure: Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
timeFrame: Up to 7 days
measure: Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
timeFrame: Up to discharge on dosing day
measure: Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
timeFrame: Up to 7 days
measure: Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
timeFrame: Up to 7 days
measure: The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Pharmacodynamic assessment: The dose-related psychoactive effects of GH002 as evaluated by a Visual Analogue Scale
timeFrame: Up to 1 hour after dosing
measure: Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
timeFrame: Up to 1 hour after dosing
measure: Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
timeFrame: Up to 1 hour after dosing
measure: Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
timeFrame: Up to 1 hour after dosing
measure: PK/PD relationship(s) of 5-MeO-DMT
timeFrame: Up to 1 hour after dosing
measure: Cognitive Function: Change from baseline in Rapid visual information processing (RVP) test
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Verbal recognition memory (VRM) test
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
timeFrame: Up to 7 days
measure: The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of bufotenine
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: GH Research Clinical Trial Site
Study officials:
References: