A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults

Inclusion Criteria:

- Male or female and age is between 18 and 55 years, inclusive.

- Women must be of non-childbearing potential and may not be pregnant, lactating, or
breast-feeding. Non-childbearing potential is defined by at least one of the following
criteria:

1. At least 2 years spontaneous amenorrhea (not attributable to environmental or
pathological causes, e.g., anorexia or excessive exercise) with
follicle-stimulating hormone (FSH) in post-menopausal range at screening;

2. At least 3 months post-surgical bilateral oophorectomy or tubal ligation; or

3. Hysterectomy (must be greater than 5 years post-hysterectomy if due to cancer);

- Females must have negative results for pregnancy tests performed:

1. At screening based on a urine specimen obtained within 28 days prior to initial
study drug administration, and

2. Prior to dosing based on a serum sample obtained on Day -1.

- If male, subject must be surgically sterile or practicing at least 1 of the following
methods of contraception, from initial study drug administration through 90 days after
administration of the last dose of study drug:

1. Partner(s) using an IUD;

2. Partner(s) using hormonal contraceptives (oral, vaginal, parenteral, or
transdermal).

3. Subject and/or partner(s) using double-barrier method (condoms, contraceptive
sponge, diaphragm, or vaginal ring with spermicidal jellies or creams);

4. Total abstinence from sexual intercourse as the preferred life style of the
subject; periodic abstinence is not acceptable.

- If male, subject agrees to abstain from sperm donation through 90 days after
administration of the last dose of study drug.

- Body Mass Index (BMI) is ≥ 18 to < 32 kg/m2, inclusive.

- A condition of general good health, based upon the results of a medical history,
physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram
(ECG), as judged by the investigator.

- Must voluntarily sign and date each informed consent, approved by an Institutional
Review Board (IRB), prior to the initiation of any screening or study-specific
procedures.

Exclusion Criteria:

- History of clinically significant drug allergies, including allergies to any of the
components of the investigational product and/or clinically significant food allergies
as determined by the investigator; History of clinically significant drug allergies,
including allergies to any of the components of the investigational product and/or
clinically significant food allergies as determined by the investigator;

- Presence or history of any significant cardiovascular, gastrointestinal, hepatic,
renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or
psychiatric disease, as determined by the investigator;

- Presence of any other condition (including surgery) known to interfere with the
absorption, distribution, metabolism, or excretion of medicines.

- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or
herbal supplements on a regular basis.

- Use of any medications (over-the-counter and/or prescription medication), vitamins,
and/or herbal supplements, within the 30-day period prior to study drug administration
or within 5 half-lives (if known), whichever is longer.

- Recent (6-month) history of drug or alcohol abuse.

- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
antibody (HCV Ab), or HIV antibodies (HIV Ab) at screening.

- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
of a transfusion of any blood product within 8 weeks prior to study drug
administration.

- Receipt of any investigational product within a time period equal to 10 half-lives of
the product, if known, or a minimum of 30 days prior to study drug administration.

- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day
-1.

- Consumption of alcohol within 72 hours prior to study drug administration.

- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or
Seville oranges within the 72-hour period prior to study drug administration.

- Use of tobacco or nicotine-containing products within the 6-month period preceding
study drug administration.

- Current enrollment in another clinical study.

- Previous enrollment in this study.

- Screening laboratory analyses that show any of the following abnormal laboratory
results:

1. Alanine transaminase (ALT) level above 1.2× the upper limit of normal (ULN).

2. Aspartate transaminase (AST) level above 1.2× the ULN.

3. Any other laboratory results that are outside of the laboratory normal reference
range and considered clinically significant by the investigator.

- Clinically-significant abnormal ECG; ECG with QTc using Fridericia's correction
formula (QTcF) > 450 msec is exclusionary.

- Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive RTA 901.