Chinook Pauses Phase 1 Trial After Adverse Effects

 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today 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 (SAE) that occurred in a single subject following the first dose in the 125 mg multiple ascending dose (MAD) 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 (FDA) through a Suspected Unexpected Severe Adverse Reaction (SUSAR) 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. 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.

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