A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
Overview
- Phase
- Phase 2
- Intervention
- T2-18C3 therapeutic antibody
- Conditions
- Type 2 Diabetes
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by blocking inflammation in the pancreas.
Detailed Description
This is a phase I, open label study of the safety and pharmacokinetics of T2-18C3 in patients with T2D. Nine patients will receive four biweekly IV infusions of the study drug, T2-18C3, at a dose level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Diabetes Association (ADA) diagnostic criteria for Type 2 Diabetes (T2D)
- •HbA1c \>7.0% and ≤ 10%
- •Current T2D duration \> 3 months at Screening
- •T2D and other diseases must be stable. Stable disease is defined as disease which did not require a change in medication or dosing level on 4 or more consecutive days or 7 days in total within 28 days prior to Day
- •Age ≥ 18 and ≤ 70 at Screening
- •BMI ≥ 23 and ≤ 40 kg/m2
- •For female patients of child-bearing age, a negative serum pregnancy test. For patients with reproductive potential, a willingness to utilize adequate contraception (oral contraception plus a mechanical barrier) and not become pregnant (or have their partner\[s\] become pregnant) during the study
- •Agrees not to change diet and exercise regimen during the trial
- •Signed and dated Ethics Committee (EC) approved informed consent before any protocol-specific screening procedures are performed
Exclusion Criteria
- •Use of the following medications:
- •Daily use of steroids or aspirin ≥ 700 mg per week
- •Immunosuppressive treatment
- •Thiazolidinediones
- •Concomitant treatment with any other therapeutic antibody, or treatment with any biologic agent that blocks the IL-1 or TNFα signaling pathway
- •Change in medication for diabetes within 28 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
- •Hemoglobin \<10.0 g/dL, WBC \<3.0 x 103/mm3 , platelet count \<125 x 103/mm3, creatinine \> 1.5mg/dL, AST/ALT \>2 x ULN, alkaline phosphatase \>2 x ULN
- •Abnormal, untreated T3, T4, thyroglobulin, or TSH levels or history of Grave's disease
- •Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody
- •History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, nonmetastatic squamous or basal cell carcinoma of the skin
Arms & Interventions
T2-18C3 therapeutic antibody
9 subjects will receive the T2-18C3 therapeutic antibody.
Intervention: T2-18C3 therapeutic antibody
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 90 days
The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry.
Secondary Outcomes
- Preliminary Efficacy(90 days)
- Pharmacokinetics(90 days)