Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)

Exclusion Criteria

• •1. Any disease or condition which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND L02 s0201, or would place the subject at increased risk.
• •2. On ongoing therapy for HCV/HBV, or received therapy for HCV/HBV within 12 weeks prior to administration of study drug.
• •3. On interferon therapy for any disease or received interferon therapy for any disease within 12 weeks prior to administration of study drug.
• •4. History of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma.
• •5. Alpha-fetoprotein (AFP) ≥ 50 ng/mL or signs of abnormality or hepatocellular carcinoma on ultrasound survey of the liver.
• •6. Carcinoembryonic antigen (CEA) levels above the ULN.
• •7. Laboratory test results include abnormal values considered to be clinically significant by the Investigator.
• •8. Participated in a concurrent interventional study with the last intervention occurring within 12 weeks prior to administration of study drug.
• •9. Taken vitamin A or vitamin D supplements or multi-vitamins that contain vitamin A or vitamin D between the screening visit and administration of study drug.
• •10. History, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid.
• •11. Veins unsuitable for repeated venipuncture or IV infusion (eg, veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
• •12. Received recent treatment with alternative therapies, which, in the opinion of the Investigator, could potentially confound clinical or laboratory assessments.
• •13. Lost more than 500 mL of blood within 56 days prior to administration of study drug.
• •14. Body mass index (BMI) \> 38 kg/m2.
• •15. History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS).
• •16. History of malignancy within the last 5 years with the exception of basal cell carcinoma.
• •17. Woman of childbearing potential.
• •18. History of hypersensitivity to H2-receptor antagonists.
• •19. Any other reason that, in the opinion of the Investigator or the Sponsor's Medical Monitor, makes the subject unsuitable for enrollment.