[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and meal timing effects of single and multiple oral administrations of MWN109 tablets in Chinese study participants
主要目的:
评估 MWN109 片在中国参与者中单、多次给药的安全性、耐受性。
次要目的:
评估 MWN109 片及其辅料沙波立沙钠(SNAC)在中国参与者中单、多次给药的药代动力学特征。
评价进餐时间对 MWN109 片药代动力学特征的影响。
探索性目的:
初步评估 MWN109 片在中国参与者中的药效学特征。
初步评估 MWN109 片在中国参与者中的免疫原性。
[Translation] Primary objective:
To evaluate the safety and tolerability of MWN109 tablets in Chinese participants after single and multiple administrations.
Secondary objective:
To evaluate the pharmacokinetic characteristics of MWN109 tablets and its excipient sabolic steroid sodium (SNAC) in Chinese participants after single and multiple administrations.
To evaluate the effect of meal time on the pharmacokinetic characteristics of MWN109 tablets.
Exploratory objective:
To preliminarily evaluate the pharmacodynamic characteristics of MWN109 tablets in Chinese participants.
To preliminarily evaluate the immunogenicity of MWN109 tablets in Chinese participants.