Slide 1: A Phase 1, Dose-Ranging Study of Vaporized 5-MeO-DMT Formulation (GH001) in Healthy Volunteers
A Phase 1, Dose - Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5 - Methoxy - N, N - Dimethyltryptamine Formulation (GH001) in Healthy Volunteers 1 Clinicaltrials.gov ID NCT04698603 Johannes Reckweg 1 , Natasha Mason 1 , Cees van Leeuwen 1 , Stefan Toennes 2 , Theis Terwey 3
Slide 2: Disclosures
Grants The study was funded by GH Research Advisory Board/Consultant Johannes Reckweg and Jan Ramaekers work as consultants for GH Research 2 Disclosures GH001 - TRD - 102 ECNP 2022 – Poster P.0665
Slide 3: 5-MeO-DMT and GH001
• 5 - MeO - DMT (5 - Methoxy - N,N - Dimethyltryptamine) • Naturally - occurring psychoactive substance from tryptamine class • Highly potent agonist on 5 - HT1A and 5 - HT2A receptors • Psychoactive effects with ultra - rapid onset (within seconds) and short duration (5 to 30 min) • GH001 ( 5 - MeO
Slide 4: 5-MeO-DMT and Peak Experiences
5 - MeO - DMT and Peak Experiences • High propensity to induce peak experiences (PE) • Feelings of ego dissolution • Experience of unity or oneness • Profound and meaningful • May be a surrogate marker for therapeutic effects • Assessed through proprietary Peak Experience Scale • Three visual analog
Slide 5: Phase 1 Trial in Healthy Volunteers (GH001-HV-101, n=22)
Phase 1 Trial in Healthy Volunteers (GH001 - HV - 101, n=22) • GH001 single doses of 2 mg, 6 mg, 12 mg, 18 mg and GH001 IDR (6, 12, 18 mg intra - subject dose escalation) • No SAEs, all ADRs mild (except two moderate), all ADRs resolved spontaneously, inhalation well - tolerated • GH001 single dose
Slide 6: Conclusions
6 • GH001 has promising safety profile • GH001 allows rapid and individualized dosing optimization • IDR could be used in clinical applications Contacts GH Research: info@ghres.com / clinicaltrials@ghres.com Maastricht University: johannes.reckweg@maastrichtuniversity.nl / j.ramaekers@maastrichtuniv