The trial enrolled healthy subjects to assess the safety and tolerability of the varying oral doses of the asset. Credit: Chokniti-Studio / Shutterstock.

Kangpu Biopharmaceuticals has announced the completion of a bridging clinical study of KPG-818 in China.

The double-blind, randomised, placebo-controlled, trial enrolled healthy subjects to assess the safety and tolerability of the varying oral doses of the asset.

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It also examined the food effects on the pharmacokinetics of KPG-818.

The trial enrolled both male and female healthy participants who were given KPG-818 over a 14-day treatment period, followed by a four-week follow-up.

It included a total of 30 participants who were divided into three escalating cohorts, with doses ranging from 0.15mg to 2mg, and a separate cohort examined the effects of food on a 0.6mg dose.

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According to the findings, KPG-818 demonstrated to have a favourable safety profile without any serious adverse events reported.

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The most common adverse events were grades 1-2 pruritus or rash.

The pharmacokinetics of KPG-818 showed close to linear behaviour within the dosing range, and food intake did not significantly alter the drug’s exposure.

KPG-818 is designed as a small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN.

The asset showed promising results in a Phase Ib/IIa study in systemic lupus erythematosus (SLE) patients in the US.

In March 2023, Kangpu completed participant enrolment for the Phase IIa trial of KPG-818 to treat SLE, a complex, heterogeneous, inflammatory, chronic auto-immune disease, in the US.

According to the findings, 0.15mg and 0.6mg doses of KPG-818 were generally well tolerated following 12 weeks of dosing.

Compared to the placebo group, the 0.15mg group demonstrated improvements in SLEDAI-2K and CLASI scores at week 12.

The double-blind, multicentre, placebo-controlled, randomised trial was designed to assess the pharmacokinetics, tolerability, preliminary efficacy, and safety of KPG-818 in SLE patients.