- |||||||||| dimethyltryptamine (SPL026) / Cybin
Clinical, P1 data, PK/PD data, Journal: Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants: a randomized, placebo-controlled phase 1 trial. (Pubmed Central) - Jan 26, 2024 P1/2 Using the analysis of the safety, tolerability, PD, PK results, doses of 21.5?mg SPL026 were the most likely to provide an intense, tolerated experience. Based on the data obtained from this part of the trial, a dose of 21.5?mg SPL026 given as a 2-phase IV infusion over 10?min (6?mg/5?min and 15.5?mg/5?min) was selected as the dose to be taken into patients in Part B (to be presented in a future manuscript).Clinical trial registration:www.clinicaltrials.gov, identifier NCT04673383; https://www.clinicaltrialsregister.eu, identifier 2020-000251-13; https://www.isrctn.com/, identifier ISRCTN63465876.
- |||||||||| psilocybin sublingual (CYB001) / Cybin
Trial completion date, Trial primary completion date: Comparing the Effects of Psilocin and Psilocybin in Healthy Adults (clinicaltrials.gov) - Dec 15, 2023 P1, N=20, Recruiting, Based on the data obtained from this part of the trial, a dose of 21.5?mg SPL026 given as a 2-phase IV infusion over 10?min (6?mg/5?min and 15.5?mg/5?min) was selected as the dose to be taken into patients in Part B (to be presented in a future manuscript).Clinical trial registration:www.clinicaltrials.gov, identifier NCT04673383; https://www.clinicaltrialsregister.eu, identifier 2020-000251-13; https://www.isrctn.com/, identifier ISRCTN63465876. Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
- |||||||||| dimethyltryptamine (SPL026) / Cybin
Trial completion, Combination therapy: SPL026 With or Without SSRIs in Participants With MDD (clinicaltrials.gov) - Aug 14, 2023 P1, N=18, Completed, Trial completion date: Oct 2023 --> Jan 2024 Active, not recruiting --> Completed
- |||||||||| dimethyltryptamine (SPL026) / Cybin
Enrollment closed, Trial primary completion date, Combination therapy: SPL026 With or Without SSRIs in Participants With MDD (clinicaltrials.gov) - Jul 5, 2023 P1, N=19, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Aug 2023
- |||||||||| dimethyltryptamine (SPL026) / Cybin
Trial completion: IM and IV SPL026 Drug Product in Healthy Participants (clinicaltrials.gov) - Jul 5, 2023 P1, N=14, Completed, Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Aug 2023 Active, not recruiting --> Completed
- |||||||||| dimethyltryptamine (SPL026) / Cybin
Trial completion date, Trial primary completion date: IM and IV SPL026 Drug Product in Healthy Participants (clinicaltrials.gov) - Apr 12, 2023 P1, N=14, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Mar 2023 --> Jun 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| deuterated psilocybin analog (CYB003) / Cybin
CYB003: A novel, orally active analog of psilocybin for the potential treatment of Major Depressive Disorder (SDCC Halls B-H) - Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_3479; These findings suggest that, compared to psilocybin, CYB003 may provide therapeutic benefit but across a shorter clinical visit and with improved dosing accuracy, resulting in improved tolerability. Based on these preclinical studies, CYB003 will progress into Phase 1/2a clinical studies in 2022.
- |||||||||| dimethyltryptamine (SPL026) / Cybin
Enrollment closed: SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients (clinicaltrials.gov) - Sep 23, 2022 P1/2, N=66, Active, not recruiting, Based on these preclinical studies, CYB003 will progress into Phase 1/2a clinical studies in 2022. Recruiting --> Active, not recruiting
|