SHANGHAI, Oct. 11, 2019 /PRNewswire/ -- Kangpu Biopharmaceuticals announced today that it has successfully completed a first-in-human phase I single ascending dose (SAD) clinical study of KPG-818 conducted in the United States.
This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants following oral administration. A total of 40 subjects were randomized to receive active drug or placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to receive active drug and 2 subjects randomized to receive placebo). Five dose levels (2, 5, 10, 20 and 30 mg) were investigated.
In the completed phase I study, there were no safety or tolerability concerns. No serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met. KPG-818 was well tolerated at all tested dose levels. KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.
The study results will assist Kangpu Biopharmaceuticals in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.
KPG-818 is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory and anti-proliferative properties as well as remarkable in vivo efficacy in myeloma and lymphoma animal models. KPG-818 is currently being developed by Kangpu Biopharmaceuticals for the treatment of SLE and hematological malignancies.
About Kangpu Biopharmaceuticals
Headquartered in Zhangjiang Hi-Tech Park, Shanghai, China, Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatments of solid tumors, hematological malignancies, auto-immune diseases as well as inflammatory disorders through novel-generation solutions including targeted protein ubiquitination and degradation. The company has developed the X-SynergyTM platform, a proprietary drug combination technology for the treatment of castration-resistant prostate cancer (CRPC/mCRPC). Kangpu is committed to outstanding sciences to develop novel and effective medicines that address significant unmet medical needs worldwide.