NCT04345120

Multiple Ascending Doses of SY-008 in Type 2 Diabetes Mellitus

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SY-008	The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.
DRUG	SY-008 matching placebo	SY-008 matching placebo

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2020-04-14
• Last updated: 2022-05-18

Locations

1 site across 1 country: China