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Phase 1CompletedNCT05526430

Mount Sinai Phase 1 single-ascending-dose study of oral harmine hydrochloride in healthy volunteers

What this study tests

First-in-human Phase 1 open-label single-ascending-dose study at the Icahn School of Medicine at Mount Sinai evaluating the safety, tolerability, and pharmacokinetics of oral harmine hydrochloride (a DYRK1A inhibitor that stimulates human beta-cell proliferation) in 25 healthy adult volunteers. Published in the Journal of Psychopharmacology (Ables et al. 2024).

Editorial review: .

Registry checked: 2026-10-26. Registry’s own update: 2024-03-15.

Most recent recorded citation date: 2024-10 (month only). Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Healthy adult volunteers aged 18–55. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
Published in Journal of Psychopharmacology (Ables et al. 2024, PMID 39252512): oral harmine HCl was well tolerated up to 200 mg (2.7 mg/kg), with transient gastrointestinal upset and mild drowsiness at the highest 300 mg dose, zero serious adverse events (0 SAEs), and no hallucinations or cardiovascular toxicity.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Safety, tolerability, and plasma pharmacokinetics of single ascending oral doses of harmine hydrochloride

The full picture

Study design and results

First-in-human Phase 1 open-label single-ascending-dose trial at the Icahn School of Medicine at Mount Sinai evaluating oral harmine hydrochloride (a DYRK1A inhibitor that stimulates human beta-cell proliferation) in 25 healthy adult volunteers. Published in the Journal of Psychopharmacology (Ables et al. 2024, PMID: 39252512), establishing that oral harmine HCl is well tolerated up to 200 mg (2.7 mg/kg) with zero serious adverse events (0 SAEs) and no hallucinations.

Sources

  1. [1]
  2. [2]
    A Phase 1 single ascending dose study of pure oral harmine in healthy volunteers · Peer-reviewed study · 2024-10 (month only) — Ables JL et al., J Psychopharmacol 2024;38(10):918-928 (PMID 39252512; DOI 10.1177/02698811241273772).