Zhi Microbial Medicine (Xinxiang) Co., Ltd.

Main study objectives: To evaluate the safety and tolerability of TM471-1 capsules after single and multiple administrations in healthy Chinese adult subjects; Secondary study objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of TM471-1 capsules after single and multiple administrations in healthy Chinese adult subjects; (2) To evaluate the effect of food on the PK parameters of TM471-1 capsules after single administration in healthy Chinese adult subjects under fasting and high-fat meal conditions; Exploratory study objectives: (1) To explore the pharmacodynamic (PD) indicators and their relationship with PK parameters after single and multiple oral administrations of TM471-1 capsules in healthy Chinese adult subjects; (2) To explore the possible metabolites in plasma after oral administration of TM471-1 capsules.

Dose escalation phase: Primary objectives: (1) To observe the safety and tolerability of oral TM471-1 capsules alone in patients with relapsed or refractory B-cell NHL; (2) To explore the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) and dose-limiting toxicity (DLT) of oral TM471-1 capsules alone in patients with relapsed or refractory B-cell NHL. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of TM471-1 capsules; (2) To evaluate the pharmacodynamic (PD) characteristics of TM471-1 capsules; (3) To preliminarily observe the anti-tumor activity of TM471-1 capsules alone. Dose expansion phase: Primary objectives: To evaluate the efficacy of TM471-1 capsules alone. Secondary objectives: (1) to evaluate the safety and tolerability of TM471-1 capsules alone; (2) to explore the distribution of TM471-1 capsules in cerebrospinal fluid.