A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects

Inclusion Criteria:

1. Are capable of giving informed consent and complying with study procedures;
2. Are between the ages of 18 and 55 years, inclusive;
3. Female subjects have a negative pregnancy test result at screening and admission tothe study site, and meet one of the following criteria:
4. Using a medically acceptable form of birth control for at least 1 month prior toscreening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral,patch, injectable or vaginal ring), implantable device (implantable rod orintrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral,patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
5. Surgically sterile for at least 3 months prior to screening by one of thefollowing means:

• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)

3. Postmenopausal, defined as the following:

• Last menstrual period greater than 12 months prior to screening
• Postmenopausal status confirmed by serum FSH and estradiol levels atscreening;

4. Considered healthy by the Investigator, based on subject's reported medical history,full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
5. Normal renal function (eGFR > 90 ml/min/1.75 m2) as determined by Investigatorfollowing review of clinical laboratory test results;
6. Non-smoker and has not been exposed to any products containing nicotine in the last 6months;
7. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50kg;
8. Willing and able to adhere to study restrictions and to be confined at the clinicalresearch center;
9. Male subjects must agree to utilize a highly effective method of contraception (condomplus spermicide) during heterosexual intercourse from clinic admission until 12 weeksfollowing the end of study visit;
10. Male subjects with female partners of child-bearing potential must agree to usecondoms for the duration of the study and until 12 weeks after dosing with the studydrug and must refrain from donating sperm for this same period.

Exclusion Criteria:

1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by theInvestigator;
2. Known or suspected malignancy;
3. Reported history of pancreatitis or gall stones;
4. Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
5. Family history of long QTc syndrome;
6. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies orintolerance;
7. Poor venous access;
8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgGand IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening;
9. Donated or lost >500 mL of blood in the previous 3 months prior to screening;
10. Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives) prior to first dose of study drug, whichever is longer;
11. Taken any prescription medications (with the exception of hormonal contraceptive)within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
12. Hospital admission or major surgery within 6 months prior to screening;
13. A history of prescription drug abuse, or illicit drug use within 9 months prior toscreening;
14. A history of alcohol abuse according to medical history (≥ 2 drinks per day for maleand ≥ 1 drink per day for female) within 9 months prior to screening;
15. A positive screen for alcohol, drugs of abuse at screening or admission;
16. An unwillingness or inability to comply with food and beverage restrictions duringstudy participation;
17. Use of over-the-counter (OTC) medication within 7 days, and/or herbal medications (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to firstdose of study drug (Note: Use of acetaminophen at < 2 g/day is permitted until 24hours prior to dosing);
18. Any condition or finding that in the Investigators opinion would put the subject orstudy conduct at risk if the subject were to participate in the study.