NCT04119947

Single Ascending Oral Doses of SY-009 in Healthy Subjects

Evaluation of Safety, Tolerance and Pharmacokinetics/Pharmacodynamics of SY-009 Capsules After Single Dose Incremental Oral Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects.

Detailed description

This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-009 capsule for Chinese healthy subjects. Plan to screening no more than 64 healthy subjects ， dividing them into 7 dose groups.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	SY-009	The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2019-10-09
• Last updated: 2019-10-10

Locations

1 site across 1 country: China