Cybin has dosed the last patient in Part B of its three-part CYB004-E Phase I clinical trial of CYB004 in healthy volunteers.
CYB004 is being evaluated as a potential therapy for the treatment of generalised anxiety disorder with or without major depressive disorder.
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The study is evaluating the pharmacokinetics, pharmacodynamics, and safety of escalating doses of intravenous N,N-dimethyltryptamine (IV DMT) molecule CYB004 in healthy subjects.
Being conducted at the Centre for Human Drug Research in the Netherlands, the CYB004-E study is said to be one of the largest Phase I DMT trials till date.
Cybin CEO Doug Drysdale said: “We are pleased with the continued progress we are making with our CYB004 programme and excited to reach our next key milestone of first-in-human dosing with our novel CYB004 molecule.
“Through Part C of the trial, we will have the ability to evaluate CYB004 in humans earlier than expected and potentially demonstrate the advantages of deuteration on pharmacokinetic/pharmacodynamic parameters, enabling a less invasive and more convenient dose form that may eliminate the need for specialised and costly clinical centres for dosing.”
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By GlobalDataPart C of the study intends to evaluate IV bolus along with infusion regimens of CYB004 in a crossover manner.
For further clinical trials, dose selection and formulation will be decided based on the results of Part B and C studies.
Topline data from the completed Phase I study is expected in the third quarter of this year.
