Policy & Regulation
Kangpu Biopharmaceuticals completes first-in-human phase one single ascending dose clinical study of KPG-818 in US
11 October 2019 -

Kangpu Biopharmaceuticals, a China-based clinical stage company, announced today that it has completed a first-in-human phase one single ascending dose clinical study of KPG-818 conducted in the United States.

This randomised, double-blind, placebo-controlled study assessed the safety, tolerability and pharmacokinetics of KPG-818 in healthy male and female participants following oral administration. The company randomised a total of 40 patients to receive active drug or placebo in a double-blind fashion (eight patients in each dose cohort, six patients randomised to receive active drug and 2 subjects randomised to receive placebo). Five dose levels (2, 5, 10, 20 and 30mg) were investigated. The product is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN.

The study results will assist the company in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus or haematological malignancies.

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