NCT03462589

Single Ascending Oral Doses of SY-008 in Healthy Subjects

Randomized, Double-blind, Placebo-controlled, Dose Escalated Tolerance and Pharmacokinetic / Pharmacodynamic Studies of SY-008 Capsules Administered by Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (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-008 in healthy subjects.

Detailed description

This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-008 capsule for Chinese healthy subjects. Plan to screening total of 54 healthy subjects ， dividing them into 6 dose groups.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	SY-008	The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.

Timeline

• Start date: 2018-08-02
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2018-03-12
• Last updated: 2019-10-10

Locations

1 site across 1 country: China