Antibe gets Health Canada nod to start phase I study of ATB-346

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Antibe Therapeutics is pleased to announce that it has received regulatory approval to begin its Phase I clinical trial programme Health Canada issued a ‘No Objection Letter’ in response to Antibe’s Clinical Trial Application allowing the company to initiate its study entitled ‘A Double-Blind, Placebo-Controlled, Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single/Multiple Ascending Doses of ATB-346 Orally Administered in Healthy Male and Female Subjects.’ This approval represents a significant milestone on Antibe’s well-defined pathway for the development of ATB-346.

John Wallace, Antibe’s CSO, said, “We are excited to have received approval from Health Canada to begin studies of ATB-346 in humans. We look forward to characterising the drug’s effects in healthy subjects in our planned Phase I clinical programme, scheduled to start next week. The data from these studies will enable us to optimise the design of our proof-of-concept trials.”

Source: PharmaBiz


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