Nonalcoholic Steatohepatitis
Conditions
Brief summary
This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.
Detailed description
PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.
Interventions
DRUGOKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Sponsors
NasVax Ltd
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who have completed the informed consent process culminating with written informed consent by the subject. 2. Men and women age 18 to 75 years (inclusive) 3. Patients with biopsy proven NASH within the last 3 years 4. Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance. 5. HBA1C between 5.5 and 14%.
Exclusion criteria
1. Subjects who have undergone surgery within the last 3 months. 2. Subjects who have had a prior gastrointestinal surgery. 3. Subjects with a clinically significant infectious, immune mediated or malignant disease 4. Subjects who are receiving an elemental diet or parenteral nutrition. 5. Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks 6. Subjects who have received either methotrexate or cyclosporine or anti TNF-β (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months. 7. Subjects with a history of coagulopathy. 8. Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers. 9. Subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason. 10. Subjects who are HIV-positive. 11. Subjects who are HBV-positive 12. Subjects who are HCV-positive. 13. Subjects with active CMV 14. Subjects with anemia (Hb \<10.5 gm/dl). 15. Subjects with thrombocytopenia (platelets \<100K/µl). 16. Subjects with lymphopenia (absolute lymphocyte count \<0.7). 17. Subjects with IgG anti-cardiolipin antibody \>16 IU. 18. Prior exposure to anti-CD3 MAb. 19. Known sensitivity to any ingredients in the study drug 20. Any know autoimmune disease except for the studied disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome. | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| This clinical study also will include evaluations for markers of efficacy, as described below. | 60 days |
Countries
Israel
Outcome results
None listed