We canβt show the full text here under this license. Use the link below to read it at the source.
Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants
Safety, body processing, and mind effects of increasing doses of nasal BPL-003 in healthy volunteers
AI simplified
Abstract
BPL-003, a novel intranasal formulation of , was well tolerated at doses up to 12 mg with no serious adverse events.
- Most adverse events were mild, including nasal discomfort, nausea, headache, and vomiting.
- 5-MeO-DMT was rapidly absorbed, reaching peak plasma concentration in approximately 8-10 minutes.
- The mean terminal elimination half-life of 5-MeO-DMT was less than 27 minutes.
- Systemic exposure to 5-MeO-DMT increased approximately dose-proportionally.
- 60% of participants reported a 'complete ' at the 10 and 12 mg doses.
- Profound consciousness-altering effects were observed, characterized by rapid onset and short duration.
AI simplified
Key numbers
60%
Complete Rate
Percentage of participants achieving a complete at 10 and 12 mg doses.
21 of 44
Participants with Treatment-Emergent Adverse Events
Total number of participants experiencing any treatment-emergent adverse events.
8-10 min
Median Time to Peak Plasma Concentration
Time taken to reach peak plasma concentration after administration of BPL-003.