None listed
Conditions
Brief summary
This is a randomised, double-masked, placebo-controlled, single and multiple Ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of SBI-100 Ophthalmic Emulsion in healthy adult participants. The study will enroll 48 healthy volunteers who will receive either study drug or placebo at the stay-in centre where they will be observed for any changes during the course of study period.
Interventions
SBI-100 Ophthalmic Emulsion or placebo will be administered as a single approximately 35 µL drop unilaterally to the study eye only, using a masked, Sponsor-approved dropper bottle. The participants will check in to the clinic where the drug will be dispensed and remained confined to the Clinical Research Unit (CRU) until the discharge. The participants in SAD cohort will be confined to CRU for 2 days and those in MAD cohort will be in CRU for a period of 7 days. The strategies used to monitor a
SBI-100 Ophthalmic Emulsion or placebo will be administered as a single approximately 35 µL drop unilaterally to the study eye only, using a masked, Sponsor-approved dropper bottle. The participants will check in to the clinic where the drug will be dispensed and remained confined to the Clinical Research Unit (CRU) until the discharge. The participants in SAD cohort will be confined to CRU for 2 days and those in MAD cohort will be in CRU for a period of 7 days. The strategies used to monitor adherence will be supervised dosing. The study consists of two parts: Part A- Single Ascending dose: 3 cohorts of 8 participants randomized 6 (Study drug) and 2(Placebo) Cohort A1: 1 single dose in right eye of 5.0 mg/mL (0.50%) of study drug or Placebo Cohort A2: 1 single dose in right eye of 10.0 mg/mL (1.0%) of study drug or Placebo Cohort A3: 1 single dose in right eye of 20.0 mg/mL (2.0%) of study drug or Placebo Dose escalation will proceed after review of safety information and approval by the SRC. Part B will commence once the safety information is available for at least 6-8 participants from Cohort A1 and A2 of Part A. The Participants in Part A are distinct from the participants of Part B. Part B- Multiple Ascending Dose: The MAD part of the study will assess the safety and tolerability of study drug in healthy adult participants at 3 escalating cohorts with 8 participants each where 6 will receive study drug and 2 placebo in a sequential dose cohort manner. Cohort B1: Twice daily in right eye of 5.0 mg/mL (0.50%) with study drug or placebo for 5 days Cohort B2: Twice daily in right eye of 10.0 mg/mL (1.0%) with study drug or placebo for 5 days Cohort B3: Twice daily in right eye of 20.0 mg/mL (2.0%) with study drug or placebo for 5 days Sequential dose cohorts of SBI-100 Ophthalmic Emulsion (with placebo-control) are planned. All cohorts will consist of 8 participants (6 participants randomised to receive SBI-100 Ophthalmic Emulsion and 2 participants randomised to receive placebo). Dose escalations will proceed after the review of available safety information and approval by the safety Review committee (SRC).
Sponsors
Skye Biosciences,Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, 18 to 60 years of age at Screening. 2. Body mass index (BMI) (greater than or equal to) 18.0 and (less than or equal to) 32.0 kg/m2 and weighs at least 50 kg at Screening. 3. Medically healthy based on medical history, physical examination, vital signs, ECGs, or laboratory tests, prior to day 1, in the opinion of the Investigator/designee would not interfere with the study. 4. Habitual visual acuity (VA) at Screening in each eye of 20 /40 or better. 5. Medically healthy eye condition with 2 normal (non-diseased) eyes, with no anatomical ocular abnormalities in the opinion of the Investigator or designee that would interfere with the study (e.g. abnormalities that prevent reliable tonometry). 6. IOP as measured by iCare tonometer in each eye of (greater than or equal to) 10 to (less than or equal to) 21 mmHg at Screening with a difference of (less than or equal to)3 mmHg between each eye. 7. Central corneal thickness in each eye (greater than or equal to) 500 µm and (less than or equal to) 600 µm as measured by optical coherence tomography (OCT) at Screening. 8. To be able to follow contraceptive measures as specified in the protocol. 9. Willing and able to provide voluntary written informed consent prior to any study-related procedures and to comply with all study requirements and instructions.
Exclusion criteria
A participant who meets any of the following exclusion criteria must be excluded from the study: 1. Unable to discontinue contact lens use during study visits including confinement at the study site. 2. 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. 3. 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). 4. Any prior history of herpes simplex keratitis or herpes zoster keratitis in either eye. 5. History of diabetic retinopathy, diabetic macular oedema, or para/central retinal degeneration. 6. 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.). 7. History of cauterisation of the punctum or punctal plug (silicone or collagen) insertion or removal. 8. Use of ophthalmic topical steroids, topical non-steroidal anti-inflammatories, or ocular hypotensive medications within 3 months prior to screening. 9. Use of over-the-counter (OTC) vasoconstrictors/decongestants within past 7 days of Day 1. 10. Conjunctival and/or limbal hyperemia of Grade > 1 on the Efron grading scale. 11. Corneal fluorescein staining Grade > 1 on the Oxford grading scale. 12. 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. 13. Known personal or family history of congenital long QT syndrome or known family history of sudden death. 14. 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 15. Recent (within last 3 years) history of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness. 16. 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. 17. 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. 18. 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. 19. 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). 20. 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.
Outcome results
None listed