NCT05526430

Study of Harmine in Healthy Subjects

A Phase I Dose Escalation Study of Harmine in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: James Murrough · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine.

Detailed description

The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine. Harmine will be administered in an open-label, dose escalation design that will use the continual reassessment method to inform the next dose to test in a subject. There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. On the treatment day, subjects will undergo continuous medical monitoring. All adverse events will be documented and events that qualify as dose limiting toxicities (DLTs) will be used to inform dosing for the subsequent subjects.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Harmine Hydrochloride Capsules	capsules taken orally

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2022-09-02
• Last updated: 2025-01-16
• Results posted: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study