A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Biological: PlaceboBiological: MEDI-4166
- Registration Number
- NCT02524782
- Lead Sponsor
- MedImmune LLC
- Brief Summary
A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
- Detailed Description
This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- Type 2 Diabetes, ages 18-65
- Must provide written informed consent
- BMI>=25 and =<42
- Venous access suitable for multiple cannulations
- Vital signs within normal specified ranges
- Females must be non-lactating and non-childbearing potential
- Males must practice 2 effective contraceptive measures if sexually active
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- History of cancer, with the exception of basal cell carcinoma or carcinoma of the cervix
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening
- Current or previous use of systemic corticosteroids within the past 28 days prior to screening
- Use of any medicinal products or herbal preparations licensed for weight loss is prohibited.
- Positive drug screen
- Type 1 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered subcutaneously MEDI-4166 MEDI-4166 MEDI-4166 administered subcutaneously
- Primary Outcome Measures
Name Time Method Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 43 days post dosing Physical examination
Part B: Change in LDL-C from baseline to Day 36 36 days post dosing Part B: Change in LDL-C from baseline to Day 36
Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36 36 days post dosing Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36
- Secondary Outcome Measures
Name Time Method Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 71 days post dosing Physical examination
Part B: Change from baseline in fructosamine levels 36 days post dosing Part B: Change from baseline in fructosamine levels
Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) 71 days post dosing Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166 43 days post dosing Part A: Proportion of subjects with ADA to MEDI4166
Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) 43 days post dosing Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)
Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) 71 days post dosing Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) 43 days post dosing Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)
Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) 43 days post dosing Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) 71 days post dosing Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)
Part A: Change from baseline in LDL-C 43 days post dosing Part A: Change from baseline in LDL-C
Part B: Proportion of subjects with ADA to MEDI4166 71 days post dosing Part B: Proportion of subjects with ADA to MEDI4166
Part A: Change from baseline in glucose AUC up to 240 minutes 43 days post dosing Part A: Change from baseline in glucose AUC up to 240 minutes
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States