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MinimumDamageon Mar 04, 2021 10:02am
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Kalytera June 16, 2020 news release Phase 1
Kalytera June 16, 2020 news release Phase 1
The study will be initiated during the third quarter, and we expect it to be completed during fourth quarter this year.
Kalytera and Salzman Group have already begun working together to advance R-107 into Phase 1 clinical testing,” stated Robert Farrell, President and CEO of Kalytera. “We plan to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Authority (FDA) later this month in support of a first-in-human Phase 1 clinical trial. We are planning to carry out this Phase 1 safety and pharmacokinetic study of intramuscular R-107 using a single dose escalation design in 32 healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia.