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An adaptive, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the pharmacodynamics, pharmacokinetics and safety of a target controlled intravenous infusion of N,N-dimethyltryptamine (DMT) in healthy smokers

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An adaptive, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the pharmacodynamics, pharmacokinetics and safety of a target controlled intravenous infusion of N,N-dimethyltryptamine (DMT) in healthy smokers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs N-N-dimethyltryptamine (Primary)
  • Indications Smoking withdrawal
  • Focus Adverse reactions; First in man
  • Acronyms CYB004-E
  • Sponsors Entheon Biomedical

    • Most Recent Events

    • 31 Oct 2023 According to a Cybin Inc. media release, result from the phase 1 potion of this trial anticipated before the end of 2023
    • 15 Aug 2023 According to Cybin media release, CYB004 dosing underway is Part C of the Company's three-part this Phase 1 CYB004-E clinical trial and topline data from this study is expected in Q3/Q4 2023.
    • 09 May 2023 According to Cybin media release, the company announced the completion of dosing the last subject in Part B of this trial; Cybin intends to initiate Part C of the study, The Company expects to report topline data from the completed Phase 1 study in the third quarter of calendar year 2023.

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