Cybin has dosed the first healthy volunteers in the ongoing Part C of Phase I study of CYB004 to treat generalised anxiety disorder.
CYB004 is a deuterated dimethyltryptamine (dDMT) molecule that activates the 5-HT2A receptor and has the potential to overcome existing DMT limitations.
Part C is a part of the CYB004-E Phase I trial, which is designed to evaluate the safety, pharmacokinetic and pharmacodynamic of escalating CYB004 doses against DMT in healthy volunteers.
Parts A and B of the Phase I study were completed earlier.
The crossover Part C study will assess IV bolus along with infusion regimens of CYB004 in up to two cohorts.
Psychedelic effects were observed within two minutes and reached a peak at about 13 minutes.
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No safety concerns were observed in the initial participants.
Findings from Part C and the completed Part B will be used to decide the formulation and optimal dosing for further CYB004 clinical studies.
Cybin CEO Doug Drysdale said: “We plan to leverage these findings to support our goal of developing a differentiated psychedelic-based therapeutic with an optimal treatment profile that may offer less invasive and more convenient dosing methods to provide new and improved treatment options for patients and providers.
“We are proud of the speed in which we have advanced this CYB004 programme and look forward to sharing topline results later this year, along with additional topline efficacy data from our lead clinical programme, CYB003, which is currently being studied in patients with Major Depressive Disorder.
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 clinical trials till date.
CYB004 is protected by a US composition of matter patent through 2041.