Liver Test Study of Using JKB-122 in HCV-Positive Patients

Inclusion Criteria:

1. Is male or female, 18 years to 65 years of age.

2. If female of childbearing potential, must not be pregnant or breastfeeding and eitherpostmenopausal (no menses for previous 12 months) or using an effective method ofbirth control (e.g., oral contraceptives, hormonal injectable or implantedcontraceptives, tubal ligation, or partner with vasectomy plus a barrier method).

3. Is HCV positive (documented by HCV RNA testing at Screening). Chronic hepatitis C isdefined as a) Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6months before screening, and positive for HCV RNA and anti-HCV antibody at the timeof screening; or b) Positive for anti-HCV antibody and HCV RNA at the time ofscreening with a liver biopsy consistent with chronic HCV infection (or a liverbiopsy performed before enrollment with evidence of CHC disease, such as the presenceof fibrosis), according to "Guidance for Industry. Chronic Hepatitis C VirusInfection: Developing Direct-Acting Antiviral Agents for Treatment".

4. Has previous results from HCV genotype testing. If previous results are notavailable, such testing should be performed at Screening.

5. Has had a liver biopsy or Fibroscan™ within 3 years.

6. Has minimal hepatic dysfunction, defined as follows:

• Stage 0, stage 1 or 2 fibrosis(according to liver biopsy or Fibroscan™ results)ALT and AST values not exceeding 5 x ULN (Baseline value for each parameter willbe calculated as the average of 3 values obtained 7 days apart, i.e., at eachscreening visit [Days -28, -21, and -14])

• Normal albumin, total bilirubin, and prothrombin time values

7. Has elevated liver test results (ALT) at least 1.5 x ULN and not exceeding 5 x ULN (Baseline value for each parameter will be calculated as the average of 3 valuesobtained 7 days apart, i.e., at each screening visit [Days -28, -21, and -14]).

8. Is refractory or null responder, which is defined as less than 2 log10 reduction inHCV RNA at week 12 of a standard or Peg Interferon/ribavirin or other anti-HCVtherapies.

9. Is intolerable to, or relapsed from previous interferon-based therapies or otheranti-HCV therapies. Relapser is defined as HCV RNA undetectable at the end oftreatment with a standard or pegylated interferon-based regimen or other anti-HCVtherapies, but HCV RNA detectable within 24 weeks of treatment follow-up. Theintolerable is defined as HCV patients who cannot tolerate the side effects ofprevious interferon-based therapies or other anti-HCV therapies, or who were notsuitable for interferon-based therapies or other anti-HCV therapies.

10. Is opioid-free for at least 10 days prior to the first screening visit (Day -28).

11. Has not been treated with interferon-based therapies (pegylated or standard), eitheralone or in combination with ribavirin, or other anti-HCV therapies for at least 12weeks prior to the first screening visit (Day -28).

12. Is capable of understanding and signing the informed consent document. If subject isunable to sign the informed consent form, then the subject's legal representative orguardian may provide written consent per state and institution guidelines.

13. Agrees to comply with protocol requirements.

Exclusion Criteria:

1. Has history of allergy to JKB-122 or related compounds

2. Has human immunodeficiency virus (HIV) or is hepatitis B positive

3. Has history of opioid abuse

4. Has history of liver cirrhosis

5. Has positive urine drug screen at Screening

6. Is currently consuming greater than 30 g of alcohol per day (eg, 2 highballs with 1shot each, or 2 beers) or has consumed greater than 2 glasses of alcohol per daywithin 3 months prior to the first screening visit (Day -28)

7. Is being treated with any prescription narcotic drug (including transdermal deliverysystems)

8. Has a known or suspected central nervous system disorder that may predispose toseizures or lower the seizure threshold

9. Has significant history of hypertension

10. Has received other therapies for HCV infection (interferon, pegylated interferon,ribavirin, or others) in the last 12 weeks prior to the first screening visit (Day -28)

11. Requires concomitant use of or treatment with opioids or other excluded drugs such ashepatotoxic medications

12. Has received other investigational agents within 30 days prior to the first screeningvisit (Day -28)

13. Has a disease that would require chronic use of prescription corticosteroids

14. Has either autoimmune or genetic liver disease

15. May be chronically or latently infected with microbial agents other than HCV

16. Has impaired renal function (i.e. serum creatinine > 1.5xULN or serum creatinine > 2mg/dl)

17. Has BMI> 30 or BMI <18