Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04345120
Brief 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).
Detailed 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:
NCT04345120
Study Brief:
Protocol Section:
NCT04345120