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)

Completed · Phase 1

Conditions studied: Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)

In brief

The purpose of this study is to evaluate the safety and tolerability of multiple doses of ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.

Key facts

Study ID

NCT02227459

Run by

Bristol-Myers Squibb

People needed

25

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 and 75 years
• Diagnosis of METAVIR F3-4 hepatic fibrosis determined by liver biopsy done within 12 months before screening (Cohort 1) or at the pre-dose biopsy within 6 weeks before treatment (Cohorts 2 and 3)
• Adequate and stable synthetic hepatic function (albumin ≥ 3 g/dL, international normalized ratio [INR] ≤ 1.4 x upper limit of normal [ULN] and stable by prior medical history).
• Adequate and stable hepatic function as measured by alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamate transferase (GGTP), and total bilirubin (ALT/AST ≤ 5 x ULN, ALP ≤ 4 x ULN, GGTP ≤ 4 x ULN, bilirubin ≤ 2x ULN and stable by prior medical history).
• Platelet count ≥ 75,000/mm3, hemoglobin ≥ 10 g/dL, and white blood cell count (WBC) > 3000/µL.
• No signs of decompensated liver disease (ascites, hepatic encephalopathy, or variceal bleeding).
• No clinically significant abnormalities on 12-lead electrocardiogram (ECG).
• No other intercurrent medical conditions or infections considered clinically significant by the Investigator.
• Clinical laboratory assessments are within the laboratory limits of normal values or not considered clinically significant by the Investigator.
• Vitamin A levels at screening must be less than or equal to the upper limit of normal (ULN 95 µg/dL or 3.32 µmol/L).
• Any male subject, if sexually active, agrees to use barrier contraceptive techniques as defined in the protocol. If female, the subject must be of non-childbearing potential as defined in the protocol.
• Subjects who are active substances abusers may be enrolled at the discretion of the Principal Investigator.
• Willing and able to provide written informed consent and comply with the study procedures and visit schedule, including follow up visits.

You may not qualify if…

• 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.
• On ongoing therapy for HCV/HBV, or received therapy for HCV/HBV within 12 weeks prior to administration of study drug.
• On interferon therapy for any disease or received interferon therapy for any disease within 12 weeks prior to administration of study drug.
• History of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma.
• Alpha-fetoprotein (AFP) ≥ 50 ng/mL or signs of abnormality or hepatocellular carcinoma on ultrasound survey of the liver.
• Carcinoembryonic antigen (CEA) levels above the ULN.
• Laboratory test results include abnormal values considered to be clinically significant by the Investigator.
• Participated in a concurrent interventional study with the last intervention occurring within 12 weeks prior to administration of study drug.
• 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.
• History, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid.
• 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).
• Received recent treatment with alternative therapies, which, in the opinion of the Investigator, could potentially confound clinical or laboratory assessments.
• Lost more than 500 mL of blood within 56 days prior to administration of study drug.
• Body mass index (BMI) > 38 kg/m2.
• History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS).
• History of malignancy within the last 5 years with the exception of basal cell carcinoma.
• Woman of childbearing potential.
• History of hypersensitivity to H2-receptor antagonists.
• Any other reason that, in the opinion of the Investigator or the Sponsor's Medical Monitor, makes the subject unsuitable for enrollment.

Where it is running

• Texas Liver Institute — Austin, Texas, United States
• Tokuda Hospital — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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