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Clinical Trial Summary

This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SY-008 after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).


Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled, dose-increasing, multiple oral administration clinical trial. The planned dose increasing level was 6, 12 and 18 mg daily dose (3 administration groups). After the completion of the test and safety evaluation of the initial dose 6mg daily dose group, the main researchers of the team leader and the sponsor jointly determine whether to enter the 12mg daily dose study. After the completion of the test and safety evaluation of the 12 mg daily dose group, the main researchers of the team leader and the sponsor jointly determine whether to enter the 18 mg daily dose study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04345120
Study type Interventional
Source Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 15, 2020
Completion date December 15, 2021

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