The Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients

Inclusion criteria

Phase 1a: The subjects who are willing to participate in Phase 1a study must meet ALL of the following inclusion criteria:

• Volunteers (male and female) between the ages of 18-45
• Women have a negative pregnancy test result at the time of study.
• Clinical examination and result laboratory for 7 days before starting the trial must be inside the normal range.
• Currently not following any treatment regimen (except for using the oral contraceptive).
• Body mass index is between the range and / or not 25% difference compared to the normal BMI (Appendix 6).
• Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial

Phase 1b: Subjects willing to participate into the phase 1b study must meet ALL of the following inclusion criteria:

• Patients with chronic hepatitis C (male and female).
• Ages between 18 - 65 years old.
• Female patient (or female partners of the male patients) with negative pregnancy test results and/or apply effective contraception if still having sex during the study and for 6 months after using the last dose of Ribavirin.
• No previous treatment with IFN or IFN treatment with rapid viral response or already have completely viral response but leave the treatment early.
• HCV-RNA levels in serum > 80 IU / mL.
• The haematological and biochemical (except ALT / AST) parameters must be within normal limits.
• Body weight in the normal range of 25% difference compared to the normal BMI (Appendix 6)
• Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial

Exclusion criteria

Phase 1a: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1a study:

• With a history of drug abuse, alcohol or drug using within 1 year before taking part in the clinical trial. AUDIT-C scale (WHO) will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics.
• History of depression
• History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems. Having any interferon or antiviral therapy within 4 months before the trial
• Participate in any clinical trial within 3 months prior the testing
• Use of any drug in the last period of relatively positive test which last approximately 6 times the half-life of the drug.
• Blood donor with more than 400 mL of blood within 3 months prior the testing
• Influenza infection or cold symptoms within 2 weeks before the trial
• Having positive tests of HBV, HCV or HIV
• Breastfeeding women

Phase 1b: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1b study:

• Co-infection with hepatitis B and/or HIV.
• Hepatic Impairment
• Cirrhosis
• Positive tests with antibody of Peginterferon lambda 1 and Peginterferon alpha 2a.
• History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems.
• A history of immune disorders (eg, inflammatory bowel disease, hemorrhagic thrombocythemia, lupus erythematosus, autoimmune hemolytic anemia, autoimmune disease, scleroderma, severe psoriasis, arthritis rheumatoid ...)
• A history of severe mental illness, especially depression, especially the serious neurological condition determined as depression or serious psychological disorders, suicidal intention, or being hospitalized for mental illness, or having 1 phase of impaired function due to neuropathy.
• A history of severe epilepsy or using antiepileptic drugs.
• A history of using anti-cancer agents (including radiation therapy) or immunotherapy (including systematic corticosteroids) within 6 months before using the first testing dose or the patient may be in need of this treatment during the trial
• History of organ transplants with the presence of the graft function.
• Evidence of alcohol or drugs abuse within 1 year before the trial. AUDIT scale - C will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics
• History or evidence of severe disease or any other condition based on the investigator assessment that the subject may not be suitable for this study.
• Breastfeeding women.