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Safety and Pharmacokinetics of GH002 in Healthy Volunteers

NCT05753956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-01-25

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

5 Methoxy N,N Dimethyltryptamine

GH002 administered via i.v. bolus injection(s)

DRUG

Placebo

GH002 placebo administered via i.v. bolus injection

Sponsors & Collaborators

  • GH Research Ireland Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-11-29
Completion
2023-11-29

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753956 on ClinicalTrials.gov