Presently, the release criteria for TAK-101 are the best fit for purposed tests available. These tests include, but are not limited to: particle size measurement, particle surface charge measurement, the amount of gliadin contained within TAK-101, and the functionality of TAK-101 treatment in reducing the magnitude of delayed-type hypersensitivity (DTH) response in C57BL/6 mice primed with gliadin emulsified in completed Freund’s adjuvant (gliadin/CFA). The present proposal is to be completed over a one-year time period and is designed to test the in vivo functional biological activity of various batches of TAK-101 using the DTH assay. To test the in vivo functionality of TAK-101, the DTH model will be utilized. On Day 0, female (6-8 week old) C57BL/6 mice will be primed with gliadin/CFA via s.c. injection of 100μl of gliadin/CFA per mouse divided between three spots on the back of the mouse. The mice will then be randomized into two treatment groups (n=5 per treatment group), or more treatment groups depending on the number of TAK-101 batches to be tested within the specific experiment. The mice will receive a 2.5mg/dose of particles in a 200μl volume of sterile saline via i.v. injection. On day 7, the mice will receive a second treatment of either unloaded PLGA particles or TAK-101 respectively. On Day 14 post gliadin/CFA priming, the pre-challenge ear thickness will be measured and recorded using a Mitutoyo Dial Thickness Guage. The mice will be challenged with a control antigen (usually 10μg of ovalbumin in a 10μl volume of sterile PBS) in one ear and gliadin (10μg in a 10μl volume of sterile PBS) in the opposite ear. At 24 hours post antigen challenge, the change in ear thickness will be measured and recorded. The data will be reported as the mean change in ear thickness +/- S.E.M. for both the control antigen injected ears and gliadin injected ears.
|Effective start/end date||10/1/21 → 9/30/23|
- Takeda Development Center Americas, Inc. (AGMT 10/11/21 PWO AMD 1)
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