Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation

The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin® in healthy adult participants. A total of up to 40 participants were planned to be enrolled into Part A and Part B of the study. Part A consisted of 3 SAD cohorts (n = 8 per cohort) and Part B consisted of 2 MAD cohorts (n = 8 per cohort). Participants underwent a Screening period beginning up to 21 days for the SAD cohorts and 28 days for the MAD cohorts prior to randomization/dose administration. The Screening period was followed by admission to the clinical research unit (CRU), pre-dose assessment, post-dose assessment(s), and a final end of study (EOS)/follow-up visit. Safety and tolerability endpoints are to report the percentage and severity of unexpected or serious adverse events, including clinically significant vital signs, laboratory test results, physical examination, and/or reported clinical symptoms, and use of concomitant medications. Other endpoints to be assessed are neurocognitive impairment, altered state of consciousness, and overall well-being. Other assessments include pharmacokinetic (fasted and fed states) and pharmacodynamic endpoints.