Phase 1 Study to Assess Safety and Effects of Oral DC6001 Tablet in Healthy Chinese Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled Phase I trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral DC6001 tablets in healthy Chinese adults aged 18 to 55 years. The study includes both single ascending dose SAD and multiple ascending dose MAD parts to evaluate how the drug behaves in the body and its potential effects. The trial aims to gather detailed information on adverse events and drug concentration over time to support further development. The trial is divided into two main parts. Part 1 includes five dose groups 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg where participants receive a single dose of DC6001 or placebo under fasting and fed conditions. The 5 mg group also undergoes a food effect study to see how a high-fat meal affects drug absorption. Part 2 involves three dose groups 2 mg, 5 mg, and 10 mg where participants take DC6001 or placebo once daily for 14 days. Dose escalation proceeds sequentially, with safety reviews before moving to higher doses. Participants will undergo blood sample collections, safety assessments, physical examinations, ECGs, and laboratory tests throughout the study. Researchers will monitor adverse events for up to 28 days and measure drug levels in plasma over several hours to days after dosing. The study includes discharge safety exams after each treatment cycle and careful follow-up to evaluate tolerability and pharmacokinetic parameters. Total participation time varies depending on the study part and dosing schedule.

A Study of DC6001 Tablet in Healthy Chinese Adult Subjects