• Change versus placebo in number of subjects with adverse events [ Time Frame: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks, Part C: 11 weeks) ]
  Number of categorised adverse events will be recorded in the eCRF
• Change versus placebo in number of subjects with abnormal laboratory parameters [ Time Frame: Up to 48 hours (Part A), 24 hours after first dose (Part B and C), and 5-7 days post final dose (Part A after Single dose, Part B at 6-7 weeks, Part C at 11 weeks) ]
  Blood chemistry, haematology, urinalysis
• Change versus placebo in number of subjects with abnormal vital signs [ Time Frame: Up to 48 hours (Part A), 8 hours after first dose (Part B and C), and 5-7 days post final dose (Part A after Single dose, Part B at 6-7 weeks, Part C at 11 weeks) ]
  Heart rate (bpm), systolic and diastolic blood pressure (mmHg), Respiratory rate (bpm)
• Change versus placebo in number of subjects with abnormal electrocardiogram [ Time Frame: up to 48 hours post dose (Part A), 4 hours post final dose (Part B/C) and post dose on Days 10& 43 (Parts B&C) ]
  12 lead ECG

• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: pre dose and upto 48hrs (Part A), 12hrs after first dose (B &C). Part B: days 4-9 predose, day 10 upto 12hrs post dose, day 11 24 hrs post final dose. Part C: day 2 pre dose, day 42 pre dose and upto 12 hrs post dose, day 42 24 hrs post final dose ]
  Cmax maximum plasma concentration at steady state
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: pre dose and upto 48hrs (Part A), 12hrs after first dose (B &C). Part B: days 4-9 predose, day 10 upto 12hrs post dose, day 11 24 hrs post final dose. Part C: day 2 pre dose, day 42 pre dose and upto 12 hrs post dose, day 42 24 hrs post final dose ]
  Tmax time to reach the maximum concentration after drug administration
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: Samples: pre dose and timepoints up to 48 hours (Part A), 12 hours after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hours post dose, day 11 24 hours post final dose. Part C: day 2 pre dose, day 42 pre dose and tim ]
  AUC 0 -∞ & AUC 0-tlast (Area under the concentration-time curve)
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: Samples: pre dose and timepoints up to 48 hours (Part A), 12 hours after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hours post dose, day 11 24 hours post final dose. Part C: day 2 pre dose, day 42 pre dose and tim ]
  T1/2 the effective half-life based on drug accumulation at steady state
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: Samples: pre dose and timepoints up to 48 hours (Part A), 12 hours after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hours post dose, day 11 24 hours post final dose. Part C: day 2 pre dose, day 42 pre dose and tim ]
  Apparent total plasma clearance (CL/F)
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: Samples: pre dose and timepoints up to 48 hours (Part A), 12 hours after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hours post dose, day 11 24 hours post final dose. Part C: day 2 pre dose, day 42 pre dose and tim ]
  apparent volume of distribution (Vz/F)
• Evaluation of Pharmacokinetics of GB1211 in urine [ Time Frame: Samples pre dose and up to 48 hours post dose (Part A) ]
  amount of drug excreted in urine (Ae)
• Evaluation of Pharmacokinetics of GB1211 in urine [ Time Frame: Samples re dose and up to 48 hours post dose (Part A) ]
  renal clearance (CLR)
• Evaluation of Pharmacokinetics of GB1211 in urine [ Time Frame: Samples re dose and up to 48 hours post dose (Part A) ]
  percentage of dose excreted unchanged (fe) in urine
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: pre dose and 12 hrs after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hrs post dose, day 11 24 hrs post final dose. Part C: day 2 pre dose, day 42 pre dose and timepoints upto 12 hrs post dose, day 42 24 hrs ]
  minimum observed plasma concentration (Cmin)
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: pre dose and 12 hrs after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hrs post dose, day 11 24 hrs post final dose. Part C: day 2 pre dose, day 42 pre dose and timepoints upto 12 hrs post dose, day 42 24 hrs ]
  observed accumulation ratio based on AUC0-τ (RAAUC0-τ)
• Evaluation of Pharmacokinetics of GB1211 in plasma [ Time Frame: pre dose and 12 hrs after first dose (Part B and C). Part B: days 4-9 pre dose, day 10 timepoints upto 12 hrs post dose, day 11 24 hrs post final dose. Part C: day 2 pre dose, day 42 pre dose and timepoints upto 12 hrs post dose, day 42 24 hrs ]
  observed accumulation ratio based on Cmax (RACmax)

The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two additional cohorts A6 and A7, were added following dose escalation analysis.

The planned optional Part C was to include a multiple-dose cohort of 25 subjects with suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed as per Sponsor's decision.

• Drug: GB1211
  Hard capsules for oral use
• Drug: Placebo
  Hard capsules for oral use
  Other Name: GB1211

• Experimental: A1 - 5 mg GB1211 single dose and Placebo
  6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
  Intervention: Drug: GB1211
• Experimental: A2 - 20 mg GB1211 single dose and Placebo
  6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
  Intervention: Drug: GB1211
• Experimental: A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo
  6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.
  Intervention: Drug: GB1211
• Experimental: A4 - 100 mg GB1211 single dose and Placebo
  6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
  Intervention: Drug: GB1211
• Experimental: A5 - 200 mg GB1211 single dose and Placebo
  6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
  Intervention: Drug: GB1211
• Experimental: B1 - GB1211 multiple ascending doses, 50mg BID and Placebo
  GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.
  Intervention: Drug: GB1211
• Experimental: B2 - GB1211 multiple ascending doses, 100mg BID and Placebo
  GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule..
  Intervention: Drug: GB1211
• Experimental: A6 - 50mg GB1211 single dose and Placebo
  8 healthy subjects are administered 50 mg (10 x 5mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.
  Intervention: Drug: GB1211
• Experimental: A7 - 400 mg GB1211 single dose and Placebo
  8 healthy subjects are administered 400 mg (8 x 50mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.
  Intervention: Drug: GB1211
• Experimental: Part A - Placebo for GB1211
  In Part A - 2 subjects from each arm (A1-A5) will receive placebo.
  Intervention: Drug: Placebo
• Experimental: Part B - Placebo for GB1211 (BID)
  Part B - 3 subjects from each arm B1 and B2 will receive placebo.
  Intervention: Drug: Placebo

Inclusion Criteria:

Subjects for Parts A and B must satisfy all of the following criteria at the Screening visit unless otherwise stated:

1. Males or females, of any race, between 18 and 55 years of age (60 years for Part B), inclusive.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m^2 (inclusive) with a minimum body weight of 50 kg.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
5. Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up visit.
6. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Subjects for Parts C must satisfy all of the following criteria at the Screening visit unless otherwise stated:

1. Males or females, of any race, between 18 and 60 years of age, inclusive.
2. Body mass index (BMI) of ≥ 25.0 and ≤ 38.0 kg/m^2.
3. Documented history of fatty liver within the last 24 weeks by one of the following: magnetic resonance imaging (MRI) suggesting liver fat ≥ 8%, ultrasound (US) indicating fatty liver, or Fibroscan Controlled Attenuation Parameter (CAP) > 270 dB/m. In subjects without a documented history of fatty liver, a Fibroscan CAP or US can be performed at Screening. Subjects with Fibroscan CAP > 270 dB/m or US indicating fatty liver are eligible.
4. Metabolic syndrome (Adult Treatment Panel III definition) or T2DM (defined as stable diabetes with glycosylated haemoglobin [HbA1c] ≤ 9.5%).
5. Alanine aminotransferase (ALT) ≥ 20 U/L for females and ≥ 30 U/L for males at Screening.
6. Fibroscan ≥ 7 KPa and < 13 KPa, or Fibrosis-4 (FIB-4) index ≥ 1.1 and <3.25.
7. Females of nonchildbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or postmenopausal (defined as at least 12 months postcessation of menses without an alternative medical cause and follicle-stimulating hormone [FSH] level ≥ 40 mIU/mL). Males will agree to use contraception as detailed in protocol.
8. Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up visit.
9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

Subjects from Part A & B will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
2. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.

3 (Part A). Any of the following: a. QTcF > 450 msec confirmed by repeat measurement. b. QRS duration > 110 msec confirmed by repeat measurement. c. PR interval > 220 msec confirmed by repeat measurement. d. findings which would make QTc measurements difficult or QTc data uninterpretable. e. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).

3 (Part B). Clinically significant ECG abnormalities or QTcF greater than 450 msec for males and 470 msec for females at either Screening or Day 1 predose, or any prior history of QT abnormality.

4. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.

5. Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.

6. Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.

7. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).

8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).

9. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.

10. Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

11. Subject who, in the opinion of the Investigator (or designee), should not participate in this study.

Subjects from Part C will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

1. If diabetic and diabetes is other than T2DM.
2. Subjects, who have had bariatric surgery of any kind or, in the opinion of the Investigator, have experienced a clinically significant change in body weight within the 3 months prior to Screening.
3. History of any known serious disease (such as cancer, except skin basocellular carcinomas, major infection, clinically significant gastrointestinal disorder, major autoimmune disease) or other disease which in the Investigator's opinion would exclude the patient from the study.
4. The following clinical laboratory results at Screening: -Total Bilirubin > 2 × ULN, ALT > 155 U/L for females and > 185 U/L for males, AST > 155 U/L for females and > 200 U/L for males
5. Other abnormal clinical laboratory values that are considered clinically significant for this population.
6. Clinically significant ECG abnormalities or QTcF greater than 450 msec for males and 470 msec for females at either Screening or Day 1 predose, or any prior history of QT abnormality.
7. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
8. Alcohol consumption of > 14 units per week for males and for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
9. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
10. Positive hepatitis panel and/or positive HIV test .
11. A creatinine clearance of less than 50 mL/min (as calculated by Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) < 60 mL/[min*1.73 m²] at Screening.
12. Subject taking any antidiabetic medications, with the exception of metformin, sulfonylureas, gliptins, and sodium/glucose co-transporter 2 inhibitors, within 3 months prior to Screening.
13. Use of any of the following non-permitted medication within 6 months prior to Screening: amiodarone, bile salt chelators, methotrexate, pharmacological doses of systemic corticosteroids for at least 2 consecutive weeks, or any other medications known to affect liver function.
14. Have previously completed or withdrawn from this study investigating GB1211, and have previously received the investigational product.
15. Subject who, in the opinion of the Investigator (or designee), should not participate in this study.