AffaMed Therapeutics (HK) Ltd.

This study is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-titration study in patients with early Parkinson's disease who are not taking concomitant levodopa. It consists of 2 parts: Part A is a non-randomized, open-label, single-arm, dose-titration multicenter study, which will be conducted before Part B. Part B will be initiated only after the safety of the patients has been evaluated and confirmed in Part A. If the upper limit of the dose of the investigational drug in Part B needs to be adjusted based on the safety and pharmacokinetic results of Part A, the study protocol will be revised as necessary. The purpose of Part A: To study the safety and tolerability, pharmacokinetics and efficacy of AM006 in patients with early Parkinson's disease who are not taking levodopa, with a dose titration from 0.25mg/day to 2mg/day for a total of 10 weeks of treatment; the purpose of Part B: To evaluate the efficacy, safety and pharmacokinetics of AM006 in patients with early Parkinson's disease who are not taking levodopa, with a dose titration from 0.25mg/day to 2mg/day for a total of 16 weeks of treatment.

This study was a phase I, open-label, fixed-sequence study designed to evaluate the effect of multiple oral doses of 600 mg rifampin on the pharmacokinetics of a single oral dose of 0.5 mg AM006 in healthy subjects.