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DewDiligence

04/11/23 11:37 AM

#246348 RE: Whalatane #246327

KDNY pauses dosing_in CHK-336 phase-1 due_to SAE:

https://finance.yahoo.com/news/chinook-therapeutics-announces-voluntary-pause-120000018.html

The SAE had a rapid onset and rapid recovery; follow-up of the subject is ongoing. Based on evaluation to date with input from expert consultants, the underlying cause of the event is being investigated as a potential hypersensitivity reaction to the study drug or its excipients. Next steps will be determined once Chinook and the trial’s Safety Monitoring Committee have reviewed all safety data. Previously, CHK-336 was generally well tolerated in a total of 62 subjects at single doses up to 500 mg and multiple doses up to 60 mg daily for 14 days.

This trial is in healthy volunteers.