- Lexaria just announced the completion of batch manufacturing of its patented DehydraTECH(TM)-processed CBD and placebo materials for its FDA Phase 1b HYPER-H23-1 human clinical study
- This is in line with the company’s IND filing with the FDA, which it looks to complete this summer, with potential authorization within 60 days
- FDA authorization will mark the commencement of Phase 1b trial patient dosing, with the study evaluating the safety and tolerability of DehydraTECH-CBD in hypertensive patients
- Filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced an ambitious plan to embark on its Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study, HYER-H23-1. Earlier in May, the company announced the awarding of the contract for clinical research organization (“CRO”) services to California-based InClin, Inc. Since this announcement, it has completed batch manufacturing of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for the study (https://cnw.fm/MR9kR).
Lexaria retained the services of a U.S. contract manufacturing organization to produce these study materials, in line with current Good Manufacturing Practice (“cGMP”) regulations as directed by the FDA. With everything on track, the company looks to file the IND this summer, with potential authorization by…
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