A study to evaluate the Safety, Tolerability, and Pharmacokinetics of SBI-100 Ophthalmic Emulsion in Healthy Adult Participants

Exclusion Criteria26

• Unable to discontinue contact lens use during study visits including confinement at the study site.
• Previous ocular surgeries / procedures: such as cataract or refractive surgery (eg, radial keratotomy, photorefractive keratectomy, or laser in situ keratomileusis), and post-YAG laser capsulotomy after cataract surgery, within 12 months of Day 1. Any surgeries or procedures (including laser) to treat glaucoma prior to screening is excluded.
• Recent (within 3 months prior to Screening) or current evidence of ocular infection or inflammation in either eye (including but not limited to blepharitis, conjunctivitis, uveitis, scleritis or keratitis).
• Any prior history of herpes simplex keratitis or herpes zoster keratitis in either eye.
• History of diabetic retinopathy, diabetic macular oedema, or para/central retinal degeneration.
• History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, etc.).
• History of cauterisation of the punctum or punctal plug (silicone or collagen) insertion or removal.
• Use of ophthalmic topical steroids, topical non-steroidal anti-inflammatories, or ocular hypotensive medications within 3 months prior to screening.
• Use of over-the-counter (OTC) vasoconstrictors/decongestants within past 7 days of Day 1.
• Conjunctival and/or limbal hyperemia of Grade > 1 on the Efron grading scale.
• Corneal fluorescein staining Grade > 1 on the Oxford grading scale.
• Abnormal clinically significant ECG measurements (triplicate ECGs) at Screening or Day 1 (Pre-dose), or any of the following:
• a. Clinically significant broadened QRS complex (eg, left bundle branch block in any of the 3 ECG readings)
• b. QTcF > 450 msec (males) or > 470 msec (females) as calculated by the average of 3 ECG readings
• c. Any ECG abnormality that may compromise a participant’s safety in this study per Investigator’s discretion.
• Known personal or family history of congenital long QT syndrome or known family history of sudden death.
• Unstable vital sign(s) or the following values seen at Screening, Day-1, or Day 1 (pre dose) following 5 minutes in the semi-supine position):
• a. Systolic blood pressure < 90 mmHg or > 160 mmHg or
• b. Diastolic blood pressure < 50 mmHg or > 95 mmHg
• c. Pulse rate < 45 beats per minute (bpm) or > 105 bpm
• Recent (within last 3 years) history of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness.
• Regular smoker (more than an average of 5 cigarettes per day in the last 3 months) or unable to abstain from smoking (including the use of tobacco or nicotine products and e-cigarettes) from the time of Screening until the EOT visit.
• Unable to abstain from the use of cannabis and other cannabinoid compounds (other than the study drug) from the time of Screening until after the EOS visit.
• Known hypersensitivity reaction or allergy to cannabinoids or cannabis or to any component of the SBI-100 formulation including sesame seed/oil allergies or sensitivities.
• Positive results that indicate an active virological infection at Screening, including for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Received any prescription medication or vaccination (other than contraceptive medication) within 14 days of IP administration, or any OTC, herbal, nutritional or topical medication within 7 days prior to dose administration, and throughout the study. Vitamin administration and up to 2 g paracetamol per day is allowable prior to and during the study.