Clinical Trials

Pursuing clinical validation of a new class of endocannabinoid system-targeting medicines

Skye Bioscience is committed to applying best practices from drug design through manufacturing, preclinical and clinical development, and regulatory review. Our ambition is to clinically validate promising drug candidates that interact with the endocannabinoid system to potentially address various diseases


Phase 1 Clinical Trial: SBI-100 Ophthalmic Emulsion

Skye is conducting its first-in-human Phase 1 clinical study of SBI-100­­­ OE in Australia. The primary endpoints for this randomized, double-masked, placebo-controlled study are to assess safety and tolerability of the drug in healthy volunteers. The secondary endpoint is to assess pharmacokinetics. The study will also measure changes to intraocular pressure in the eye. A total of 48 subjects will be topically administered SBI-100 OE or placebo on a single eye in single ascending dose and multiple ascending dose arms. Eight participants will be enrolled in each of six total cohorts. In each cohort, six participants will be administered SBI-100 Ophthalmic Emulsion and two will receive placebo.

SBI-100 Ophthalmic Emulsion has a novel product profile

SBI-100 Ophthalmic Emulsion is a proprietary formulation of a synthetic prodrug rationally designed to improve the ocular solubility and permeability of a cannabinoid receptor-type 1 agonist being developed to treat glaucoma.