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GH001 Aerosol Phase 1 Trial - Pharmacokinetics and Safety in Healthy Subjects

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Summary

The NIH ClinicalTrials.gov registry records a Phase 1 clinical trial (NCT07540494) investigating the pharmacokinetic profile and safety/tolerability of GH001 (5-methoxy N,N-dimethyltryptamine) delivered via a proprietary aerosol delivery system in healthy adult subjects. The single-dose study is registered with intervention type and primary endpoints documented.

“The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.”

NIH , verbatim from source
Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

A new Phase 1 clinical trial registration appears on ClinicalTrials.gov for GH001, a 5-methoxy N,N-dimethyltryptamine compound delivered via a proprietary aerosol device. The trial's primary endpoints are single-dose pharmacokinetics and safety/tolerability in healthy adult subjects.

Affected parties include clinical research organizations conducting early-phase studies, sponsors of psychedelic or psychoactive compound programs, and institutional review boards reviewing similar protocols. Trial registration on ClinicalTrials.gov is a standard procedural requirement for federally-funded clinical research and does not itself create compliance obligations.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

Phase 1 NCT07540494 Kind: PHASE1 Apr 20, 2026

Abstract

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.

Conditions: Healthy Adult

Interventions: 5 Methoxy N,N Dimethyltryptamine, GH001 Aerosol Delivery System

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial conduct Pharmacokinetics study
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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