Chinook Therapeutics has reported results from a Phase I trial evaluating CHK-336, an oral small molecule LDHA inhibitor, in development for primary hyperoxaluria (PH) and other kidney stone disorders.
The placebo-controlled, single-centre, randomised, double-blinded study has evaluated the tolerability, safety, and pharmacokinetic (PK) profile of CHK-336 in 104 healthy volunteers (HV).
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It includes single-ascending dose (SAD) and multiple-ascending dose (MAD) studies.
A single dose of CHK-336 ranging from 15mg to 500mg on day one was given to healthy volunteers against a placebo in the SAD portion of the study.
In the MAD portion, healthy volunteers daily received multiple doses of CHK-336 ranging from 30mg to 500mg or placebo for 14 days.
CHK-336 was found to be well tolerated in HVs who received single doses up to 500 mg and multiple doses up to 60mg for 14 days.
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By GlobalDataPK was also well characterised by dose-proportional exposures and a half-life supporting once-daily dosing of CHK-336.
One serious adverse event of anaphylaxis was observed in MAD cohort HV who received one 125mg dose of CHK-336.
Chinook Therapeutics chief scientific officer Andrew King said: “The data presented from the Phase I study of CHK-336 at this year’s ERA Congress successfully demonstrates hepatic LDH target engagement in healthy volunteers and establishes proof-of-mechanism for CHK-336 to decrease hepatic oxalate production.
“As we continue to investigate the SAE observed in the 125mg MAD cohort and consider the next steps, the CHK-336 programme will remain paused.”
