Kangpu Biopharmaceuticals' KPG-818 Demonstrates Favorable Safety Profile in China Bridging Study
核心洞察
Kangpu Biopharmaceuticals (搜索) completed a bridging clinical study of KPG-818 in healthy Chinese subjects, assessing safety, tolerability, and pharmacokinetics.
The randomized, double-blind, placebo-controlled trial evaluated multiple oral doses of KPG-818 over 14 days, with a 4-week follow-up period.
Results showed KPG-818 was well-tolerated, with no serious adverse events reported and close to linear pharmacokinetics observed across the tested dose range.
Kangpu Biopharmaceuticals (搜索) has announced the successful completion of a bridging clinical study of KPG-818 in healthy subjects in China. The study was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of the drug in a Chinese population, building upon previous clinical trials conducted in the United States.
The randomized, double-blind, placebo-controlled trial included a food effect (FE) assessment. Thirty participants were enrolled and randomized into three escalating dose cohorts (n=10 each; 8 KPG-818, 2 placebo), receiving daily doses of 0.15 mg, 0.6 mg, or 2 mg, or placebo. An additional 12 participants were included in the FE cohort, receiving a single 0.6 mg dose of KPG-818 both with and without food. The treatment period lasted 14 days, followed by a 4-week follow-up.
Safety and Tolerability
The study results indicated that KPG-818 was well-tolerated among the healthy participants. No serious adverse events (SAEs) were reported. The most common adverse events (AEs) were mild (grades 1-2) pruritus or rash.
Pharmacokinetics
The pharmacokinetic analysis revealed a close to linear PK profile for KPG-818 within the tested dosing range of 0.15 mg to 2 mg. Furthermore, the study found similar drug exposure under both fed and fasted conditions, suggesting that food intake does not significantly impact KPG-818 absorption.
Mechanism of Action and Prior Clinical Data
KPG-818 is a small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN (搜索). It has previously been evaluated in a Phase Ib/IIa clinical study (NCT04643067) in patients with systemic lupus erythematosus (搜索) (SLE (搜索)) in the US, where it demonstrated promising efficacy and a favorable safety and tolerability profile.
Kangpu's Pipeline
Kangpu Biopharmaceuticals (搜索) is focused on developing innovative molecular glue-based therapeutics for autoimmune diseases, solid tumors, hematologic malignancies, and inflammatory disorders. The company utilizes proprietary technology platforms, including NeoMIDES®, gDACS®, and X-SYNERGY®.