A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD

The first phase assesses single ascending doses for EDP 305 (active drug or placebo) in
healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 14-days in
healthy subjects and also in subjects with presumptive NAFLD (i.e., obese subjects with or
without prediabetes or T2DM).

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects
randomized to receive EDP-305 or placebo.

Inclusion Criteria for all SAD and MAD Subjects::

- An informed consent document signed and dated by the subject.

- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55
years, inclusive.

- Female subjects must be of non-childbearing potential.

- All male participants who have not had a vasectomy must use effective contraception
from Day -1 to 90 days after their last dose of study drug.

- For healthy volunteers only (see below for Subjects with presumptive NAFLD): Body
mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg.

Additional Inclusion Criteria for MAD Subjects with Presumptive NAFLD:

- Body mass index of >28 and <35 kg/m2 at screening.

WITH or WITHOUT one of the following:

- Type 2 diabetes mellitus diagnosed by one of the following methods:

- As defined by the American Diabetes Association (ADA), as one of the following
criteria: a) symptoms of diabetes plus casual plasma glucose concentration >200
mg/dL (11.1 mmol/L) OR b) Fasting plasma glucose >126 mg/dL (7.0 mmol/L) OR c)
2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oGTT.

- HbA1c of at least 6.5%. --- OR---

- Prediabetes diagnosed as defined by the ADA as a) an HbA1c of 5.7% - 6.4% OR b)
fasting blood glucose of 100-125 mg/dL OR c) an oGTT 2-hour blood glucose of 140
mg/dL - 199 mg/dL.

Exclusion Criteria:

- Clinically relevant evidence or history of illness or disease.

- Pregnant or nursing females.

- History of febrile illness within 7 days prior to the first dose of study drug or
subjects with evidence of active infection.

- A positive urine drug screen at screening or Day -1.

- Current tobacco smokers or use of tobacco within 3 months prior to screening.

- Any condition possibly affecting drug absorption (e.g., gastrectomy,
cholecystectomy).

- History of regular alcohol consumption

- Participation in a clinical trial within 30 days prior to study drug administration.

- Use of prescription drugs, non-prescription drugs, dietary supplements including
Vitamin E herbal supplements, hormonal therapy/replacement or CYP3A4 substrates,
inducers and inhibitors within 14 days prior to the first dose of study medication.

Additional Exclusion Criteria for MAD Subjects with Presumptive NAFLD:

- Subjects taking any antidiabetic medication.

- Subjects with unstable proliferative retinopathy, macular oedema (fundus examination
performed in the previous year will be considered relevant on Investigator's
judgement).

- Subject has taken fibrates, statins, and/or Vitamin E within 6 weeks prior to the
first dose administration.

- Subjects with a history of bariatric surgery and any other gastrointestinal surgery
relative to weight loss.

- Subjects with common causes of secondary hepatic steatosis.