Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04345120
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Ascending Doses of SY-008 in Type 2 Diabetes Mellitus
Sponsor:
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: