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:

• 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;
• At least 3 months post-surgical bilateral oophorectomy or tubal ligation; or
• Hysterectomy (must be greater than 5 years post-hysterectomy if due to cancer);
• Females must have negative results for pregnancy tests performed:

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

• Partner(s) using an IUD;
• Partner(s) using hormonal contraceptives (oral, vaginal, parenteral, or transdermal).
• Subject and/or partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or creams);
• 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:

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