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

Inclusion Criteria: 1. Male or female volunteers, aged 18 to 65 years (inclusive at the time of consent); 2. Must have a Body Mass Index (BMI) ≥ 18 to ≤ 32 kg/m2 with weight ≥ 50 kg at Screening; 3. Must have a negative urine drug screen at the Screening visit and the day before dosing (Day -1); one repeat urine drug may be conducted for a suspected false positive result; 4. Must be willing to abstain from the use of cannabis and other cannabinoid compounds (other than the study drug) for the duration of the study (from the time of Screening until the EOS visit); 5. Must be willing to abstain from smoking (including the use of tobacco or nicotine products and e-cigarettes) for the duration of the study (from the time of Screening until the EOS visit); 6. Must not have any hepatic and/or renal impairment as judged by the PI; 7. Must be willing and able to comply with all study procedures and be available for the duration of the study (from the time of Screening until the EOS visit); 8. Must not be currently using anti-depressants (selective serotonin reuptake inhibitors \[SSRIs\], monoamine oxidase inhibitors \[MOAIs\], serotonin-norepinephrine reuptake inhibitors \[SNRIs\], or tricyclic anti-depressants \[TCAs\]) for 14 days or 5 half-lives of the drug, whichever is longer, prior to IP administration, and for the duration of the study; 9. Must not have any current or past allergic or adverse reaction or known sensitivity to olive oil, gelatin, glycerin and titanium dioxide, or to cannabinoid-like substances (including but not limited to Dronabinol/Marinol/Nabilone/marijuana/cannabis/tetrahydrocannabinol \[THC\], cannabinoid oil); 10. Females must be non-pregnant and non-lactating and must use two forms ("double contraception") of acceptable, highly effective contraception from Screening and for 12 weeks following the last dose of study drug. Double contraception is defined as a condom AND one other form of the following: 1. Established hormonal contraception (with an approved oral contraceptive pill \[OCP\]); 2. Depot or injectable birth control; 3. A vaginal ring or an intrauterine device (\[IUD\], with or without hormones); OR 4. Documented evidence of surgical sterilization as a single form of birth control, at least 6 months prior to Screening (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women, OR vasectomy for men \[with documented azoospermia 90 days after procedure\] provided that partner is the sole se…