A Randomized, Double-Masked (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Doses and Multiple Ascending Doses of STG-001 in Healthy Subjects

INTERVENTION: Intervention: STG‐001 Administration: Oral capsule Part 1: Single Ascending Dose (SAD) study Cohort 1 Fasted: STG‐001 6 active (1 at 0.2 and 5 at 1 mg) and 2 placebo Cohort 2 Fasted: STG‐001 5mg (6 active, 2 placebo) Cohort 3 Fasted and Fed : STG‐001 10mg (6 active, 2 placebo) Cohort Fasted 4: STG‐001 20mg (6 active, 2 placebo) Cohort Fasted 5: STG‐001 40mg (6 active, 2 placebo) The Fed period will be conducted in Cohort 3 after a washout period of >=28 days and, based on prior SAD data, dose of STG‐001 will be determined to be studied under fed conditions. Part 2: (Multiple Ascending Dose) MAD Study (STG‐001 starting dose to be confirmed based on SAD results and subsequent ascending dose to be determined by study investigator based on safety and PK data,). IP will be administered once daily for 7 days. Cohort 6 Fasted: STG‐001 'X' mg (7 active and 2 placebo) Cohort 7 Fasted: STG‐001 'Y' mg (7 active and 2 placebo) cohort 8 Fasted: STG‐001 'Z' mg (7 active and 2 placebo) New participants will be enrolled in each cohort. In cohort 3, participants will return after >=28 days for Fed dosing during which subjects will all receive a dose of STG‐001 within 30 minutes after completing a high‐fat meal (‐ 2 normal fried eggs, 2 slices white toast, 250 mL whole milk, 2 full rashes middle bacon, 2 serves butter for cooking, 2 serves butter for toast, 2 hash browns) The cohorts will run sequentially such that the study periods for Cohort 2 occur after Cohort 1. MAD cohort will commence after completion and safety review of SAD cohort 4. Participants in SAD and MAD cohorts will not be the same. CONDITION: Eye ‐ Diseases / disorders of the eye Stargardt’s Disease; ; Stargardt’s Disease SECONDARY OUTCOME: Part 1 and 2 ; ; ‐Time to reach Cmax (tmax). ; ; [Part 1 ; PK sample collection timepoints: Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose and Day 8 ; ; Part 2 ; PK sample collection timepoints: Day 1(Pre‐dose and 1, 2, 4, 8, 12 and 24 hours post‐dose), Day 7 (Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose) and Day 15 ; ] Part 1 and 2 ; ; ‐Area under the plasma concentration‐time curve from time 0 to infinity (AUC infinity). ; [Part 1 ; PK sample collection timepoints: Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose and Day 8 ; ; Part 2 ; PK sample collection timepoints: Day 1(Pre‐dose and 1, 2, 4, 8, 12 and 24 hours post‐dose), Day 7 (Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose) and Day 15 ; ] Part 1 and 2 ; ; ‐Terminal elimination half‐life (t1/2).[Part 1 ; PK sample collection timepoints: Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose and Day 8 ; ; Part 2 ; PK sample collection timepoints: Day 1(Pre‐dose and 1, 2, 4, 8, 12 and 24 hours post‐dose), Day 7 (Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose) and Day 15 ; ] Part 1 and 2 ; ; PD of STG‐001 (plasma RBP4 levels) parameters: % reduction from baseline, % with >60% reduction from baseline and % absolute reduction to <2 mg/dL. ; [Part 1 ; PD samples will be collected pre dose and on Days 2 and 8. ; ; Part 2 ; PD samples will be collected pre‐dose and on days 2, 7 and 15] Part 1 and 2 ; ‐Maximum observed plasma concentration (Cmax). ; [Part 1 ; PK sample collection timepoints: Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose and Day 8 ; ; Part 2 ; PK sample collection timepoints: Day 1(Pre‐dose and 1, 2, 4, 8, 12 and 24 hours post‐dose), Day 7 (Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose) and Day 15 ; ] Part 1 and 2 ; Percentage of subjects who meet the markedly abnormal criteria (clinically significant as by the clinical investigator) for safety 12‐lead ECG parameters at least once post‐dose. PRIMARY OUTCOME: Part 1: – To characterize the safety and tolerability of single PO doses of STG‐001 in healthy subjects in a food effect study.[Physical Examination: Screening and Day 3; Vitals: Screening, Day1,2,3,4 and Day 8; ECG: Screening, Day, 2, 3, Day 8; Telemetry: Day 1, 2 and 3; Lab assessments: Screening, Day 2, Day 4 and Day 8; Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8; FAF will be performed at Screening, Day 3 and Day 8; DA will be performed at Screening, Day ‐1, Day 3 and Day 8; ERG will be performed at Screening, Day 3 and Day 8; OCT will be performed at Screening, Day 3 and Day 8; AE: Screening, Day 1, 2, 3, 4 and Day 8; Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8; ; ] Part 1: The primary endpoint of the study is safety assessed by incidence and/or clinically significant changes of a combination of ocular and non‐ocular adverse events of single ascending PO doses of STG‐001. ; Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram. [Physical Examination: Screening and Day 3; Vitals: Screening, Day1,2,3,4 and Day 8; ECG: Screening, Day, 2, 3, Day 8; Telemetry: Day 1, 2 and 3; Lab assessments: Screening, Day 2, Day 4 and Day 8; Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8; FAF will be performed at Screening, Day 3 and Day 8; DA will be performed at Screening, Day ‐1, Day 3 and Day 8; ERG will be performed at Screening, Day 3 and Day 8; OCT will be performed at Screening, Day 3 and Day 8; AE: Screening, Day 1, 2, 3, 4 and Day 8; Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8 ; ] Part 2: The primary endpoint of the study is safety assessed by incidence and/or clinically significant changes of a combination of ocular and non‐ocular adverse events of multiple ascending PO doses of STG‐001.; Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram. [Physical Examination: Screening and Day 8; Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15; ECG: Screening, Day1, 2, 7,8 and Day 15; Telemetry: Day 1 to Day 9 daily; Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15; Visual Acuity , color vision and intra ocular pressure: Screening, Day 3, Day 9 and Day 15; FAF will be performed at Screening, Day 9 and Day 15; DA will be performed at Screening, Day 3, Day 9 and Day 15; ERG will be performed at Screening, Day 9 and Day 15; OCT will be performed at Screening, Day 9 and Day 15; AE: Screening, Day 1 to Day 10 all days and Day 15; Night Vision Questionnaire: Screening, Day 2, Day 9 and Day 15; ; ] ; [Part 1 ; ECG: Screening, Day, 2, 3, Day 8 ; ; Part 2 ; ECG: Screening, Day1, 2, 7,8 and Day 15 ; ; ] Part 1 and 2 ; Percentage of subjects who meet the markedly abnormal criteria for vital sign measurements at least once post‐dose. ; This is assessed based on clinical observation and Investigator's assessment.[Part 1 ; Vitals: Screening, Day1,2,3,4 and Day 8 ; ; Part 2 ; Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15 ; ; ] Parts 1 and 2 ; – Additional PK parameters will be calculated if useful in the interpretation of the data ; This is an exploratory outcome. ; [Part 1 ; PK sample collection timepoints: Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose and Day 8 ; ; Part 2 ; PK sample collection timepoints: Day 1(Pre‐dose and 1, 2, 4, 8, 12 and 24 hours post‐dose), Day 7 (Pre‐dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post‐dose) and Day 15] Parts 1 and 2 ; – Assessment of diagnostic imaging changes by DA (Dark Adaptometry)[Part 1 ; ‐DA will be performed at Screening, Day ‐1, Day 3 and Day 8 ; Part 2 ; DA ‐ will be performed at Screening, Day ‐1, Day 3, Day 9 and Day 15] Parts 1 and 2 ; – Assessment of diagnostic imaging changes by ERG (Electroretinogram)[Part 1 ; ‐ERG will be performed on Day ‐1, Day 3 and Day 8 ; Part 2 ; ERG ‐ will be performed on Day ‐1, Day 9 and Day 15] Parts 1 and 2 ; – Assessment of diagnostic imaging changes by FAF (Fundus Autoflourescence). ; [Part 1 ; ‐FAF will be performed on Day ‐1, Day 3 and Day 8 ; Part 2 ; FAF ‐ will be performed on Day ‐1, Day 9 and Day 15] Parts 1 and 2 ; – Assessment of diagnostic imaging changes through OCT (Optical Coherence Tomography). ; [Part 1 ; ‐OCT will be performed on Day ‐1, Day 3 and Day 8 ; Part 2 ; OCT‐ will be performed on Day ‐1, Day 9 and Day 15] Parts 1 and 2 ; – Additional PD parameters will be calculated if useful in the interpretation of the data. ; This is an exploratory outcome.[Part 1 ; PD sample collection timepoints: Pre‐dose, Day 5 and Day 8 ; ; Part 2 ; PD sample collection timepoints: Pre‐dose, Day 2, Day 7 and Day 15 ; ; ] Parts 1 and 2: ; Percentage of subjects who discontinue due to an AE. ; [AE will be monitored on an ongoing basis and at every visit and post dose on Day 1 in SAD cohorts and Days 1‐7 in MAD cohorts] Parts 1 and 2: ; Percentage of subjects who meet the markedly abnormal criteria for safety laboratory tests at least once post‐dose. This is assessed based on clinical observation and Investigator's assessment.[Part 1 ; Lab assessments: Screening, Day 2, Day 4 and Day 8 ; ; Part 2 ; Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15] Parts 1 and 2: ; ‐Percentage of subjects who experience at least 1 TEAE (Treatment emergent adverse events). ; Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram ; [Treatment‐emergent adverse events will be summarized by placebo, each STG‐001 dose level, cohort and STG‐001 overall for each part of the study. ; Part 1 ; Physical Examination: Screening and Day 3 ; Vitals: Screening, Day1,2,3,4 and Day 8 ; ECG: Screening, Day, 2, 3, Day 8 ; Telemetry: Day 1, 2 and 3 ; Lab assessments: Screening, Day 2, Day 4 and Day 8 ; Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8 ; FAF will be performed at Screening, Day 3 and Day 8 ; DA will be performed at Screening, Day ‐1, Day 3 and Day 8 ; ERG will be performed at Screening, Day 3 and Day 8 ; OCT will be performed at Screening, Day 3 and Day 8 ; AE: Screening, Day 1, 2, 3, 4 and Day 8 ; Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8 ; ; ; Part 2 ; Physical Examination: Screening and Day 8 ; Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15 ; ECG: Screening, Day1, 2, 7,8 and Day 15 ; Telemetry: Day 1 to Day 9 daily ; Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15 ; Visual Acuity , color vision and intra ocular pressure: Screening, Day 3, Day 9 and Day 15 ; FAF will be performed at Screening, Day 9 and Day 15 ; DA will be performed at Screening, Day 3, Day 9 and Day 15 ; ERG will be performed at Screening, Day 9 and Day 15 ; OCT will be performed at Screening, Day 9 and Day 15 ; AE: Screening, Day 1 to Day 10 all days and Day 15 ; Night Vision Questionnaire: Screening, Day 2, Day 9 and Day 15 ; ; ] INCLUSION CRITERIA: The subject must understand the study procedures and agree to participate by providing written informed consent. The subject must be willing and able to comply with all study procedures and restrictions. To be eligible for participation in this study, the subject must: 1. Understand the study procedures and agree to participate by providing written informed consent. 2. Healthy male and female subjects. 3. Subjects aged 18 to 55 years, inclusive, with BMI of 18 to 32 kg/m2, inclusive, and body weight >=50 kg. 4. Male subjects must abstain from heterosexual activities or agree to use a double barrier method of contraception from admission to the clinical unit through 90 days after the last dose of study drug and will not donate sperm during this period. Heterosexual WOCBP who are sexually active must not be pregnant upon entering the study that is confirmed by testing (i.e., serum pregnancy test with sensitivity of >=25 mIU/mL at screening, and uri