NCT05089617

To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Administration of YG1699 in Healthy Chinese Subjects: a Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multi-dose, Sequential, Bridging Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Youngene Therapeutics Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .

Detailed description

This is a randomized, double-blind, placebo-controlled, dose-ascending study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single ascending and multiple oral dose administration. The study consists of 2 parts: Part 1, SAD dose- ascending; Part 2, multi-dose ascending.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	YG1699	YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM. Drug: Placebo Placebo is the same appearance as YG1699.

Timeline

• Start date: 2022-01-09
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-10-22
• Last updated: 2023-01-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study