SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
- Conditions
- Mild-Moderate Alzheimer's DiseaseHealthy Elderly
- Interventions
- Biological: MEDI1814 for Subcutaneous InjectionBiological: MEDI1814 for IV injectionBiological: Placebo for Subcutaneous InjectionBiological: IV Placebo
- Registration Number
- NCT02036645
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Placebo IV Placebo Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. MEDI1814 Sub Cutaneous Injection MEDI1814 for Subcutaneous Injection 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort MEDI1814 IV MEDI1814 for IV injection Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. IV Placebo MEDI1814 for IV injection Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. Subcutaneous Placebo Placebo for Subcutaneous Injection 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
- Primary Outcome Measures
Name Time Method Tolerability as Measured by Participant Withdrawal for an Adverse Event 4 months SAD; 7 months MAD Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
- Secondary Outcome Measures
Name Time Method Mean Termination Half Life (t 1/2) of Medi1814 1 month Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Maximum Plasma Concentration (Cmax) of Medi1814 1 month Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed) Day 29 in SAD; Day 85 in MAD Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57) 1 month Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Biomarker: Total Amyloid-beta 1-42 in Plasma Day 29 in SAD; Day 85 in MAD Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Medi1814 Concentration in CSF Samples SAD Day 29; MAD Day 85 Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Immunogenicity: Anti-drug Antibody Titer 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests) Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all \<50
Trial Locations
- Locations (1)
Research Site
🇺🇸Salt Lake City, Utah, United States