An Open-label Phase 1b Cross-over Pharmacokinetic Relative Bioavailability Study Comparing 2 Formulations of STG-001 in Healthy Subjects

Exclusion Criteria20

• Any subject who meets any of the following criteria will not qualify for entry into the study:
• The subject has a known hypersensitivity or contraindication to any component of STG 001.
• The subject has any history of an anaphylaxis event.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and HRT must be discontinued 28 days prior to Check-in (Day -1). As an exception, paracetamol may be used at doses of less than or equal tov1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the Principal Investigator and the Sponsor.
• The subject has a history of vitamin A deficiency or clinical signs during slit lamp examination (conjunctival or corneal xerosis; Bitot’s spots; corneal ulcers of scarring not due to trauma or other secondary causes).
• Has taken non-approved items (supplement containing vitamin A or beta-carotene, liver-based products (foods, such as liverwurst, are not an exclusion), or prescription oral retinoid medications) within 30 days prior to admission at the clinical site.
• Use of medications that may interact with Vitamin A metabolism within 60 days of screening (e.g. Accutane [isotretinoin], doxycycline).
• Participation in an interventional study of a Vitamin A derivative less than or equal to 3 months prior to screening
• Presence of significant cardiovascular or cerebrovascular disease, including stroke.
• Has a clinically significant abnormal electrocardiogram (ECG), or has a corrected QT interval (QTc) that is 450 ms or greater
• Resting heart rate outside specified limits (less than 40/minute, greater than 100/min upon repeated measurement).
• History of diabetes, hepatitis, pancreatitis, cirrhosis, liver failure, uncontrolled thyroid disease or hypervitaminosis A.
• Any surgical procedure within three month of trial entry or anticipated during the trial. If such surgical procedure was within 3 months of trial entry and there was a full recovery with no expected impact on study procedures, data or safety, such a subject would be eligible at the discretion of the PI.
• Women who are pregnant or nursing.
• Abnormal blood pressure outside specified limits (90 mm Hg > Systolic > 140 mm Hg and/or 40 mm Hg > Diastolic > 90 mm Hg) upon repeated measurement.
• Clinically significant abnormal lab results at screening, including liver function test (aspartate transaminase, alanine transaminase, bilirubin and alkaline phosphatase) greater than 1.5 x the ULN
• Actively participating in an experimental therapy study or have received experimental therapy within 60 days or 5 half-lives, whichever is longer, of screening.
• Any history of significant eye disorders (including retinal disorders) or visual disturbances.
• In the PI’s opinion, any acute or chronic medical condition, psychiatric condition, physical examination finding or laboratory abnormality that may increase the risk associated with study participation or administration of study treatment or interfere with the interpretation of study results. Minor medical conditions that are not currently being treated with medication and that are not expected to interfere with study procedures, data or participant safety may be considered for inclusion at the discretion of the PI.
• Participants could be at increased risk of harm or put other people at increased risk of harm (e.g. if they are taxi or Uber drivers), if they were to experience visual impairment like impaired night time vision. Participants must agree to comply with advice of study investigators or study ophthalmologist around modifying activity and taking precautions if visual impairment occurs until such time as the visual impairment resolves, or the participant will be excluded from the study.