Binjiang Pharma, Inc.

The main purpose of the Phase IIa study is to evaluate the objective response rate (ORR) of HL-085 at a dose of 9 mg BID or further explore the RP2D dose in the treatment of adult patients with NF1 mutant plexiform neurofibromas who cannot be completely removed by surgery. The main purpose of the Phase IIb study is to evaluate the ORR of HL-085 at the RP2D dose of the Phase IIa study in the treatment of adult patients with NF1 mutant plexiform neurofibromas who cannot be completely removed by surgery.

This study aims to evaluate the material balance and biotransformation pathway of a single oral dose of 12 mg/approximately 100 μCi [14C]HL-085 in healthy adult male volunteers in China, so as to reveal the absorption, metabolism, excretion characteristics and safety of HL-085 in the human body and provide a reference for the rational use of the drug.

To evaluate the effect of a high-fat, high-calorie diet on the pharmacokinetics of a single oral dose of HL-085 capsules, and to evaluate the safety and tolerability of a single oral dose of HL-085 capsules in volunteers after a high-fat, high-calorie diet, and to provide a reference for the rational use of drugs in clinical practice.