Chinook Therapeutics announces voluntary pause in dosing o CHK-336

Chinook Therapeutics announced that dosing in the phase 1 clinical trial of CHK-336 in healthy volunteers has been voluntarily paused to allow a thorough investigation of a serious adverse event that occurred in a single subject following the first dose in the 125 mg multiple ascending dose group. Dosing was halted per trial protocol when the event occurred, followed by a voluntary pausing of the trial by Chinook to enable further investigation. The event has been reported to the U.S. Food and Drug Administration through a Suspected Unexpected Severe Adverse Reaction report. 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.