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

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).

Start Date15 Jun 2020

Sponsor / Collaborator

Suzhou Yabao Pharmaceutical R&D Co. Ltd.

CTR20200654 / CompletedPhase 1

随机双盲、安慰剂对照、剂量递增Ⅰb期研究以评价SY-008在2型糖尿病患者中的安全性、耐受性及药动/药效学特征

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of SY-008 in patients with type 2 diabetes

主要目的：评估2型糖尿病患者多次口服SY-008胶囊的安全性和耐受性。次要目的：1）评估2型糖尿病患者多次口服SY-008胶囊的药代动力学特征；2）评估2型糖尿病患者多次口服SY-008胶囊的药效动力学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of SY-008 capsules after multiple oral administration in patients with type 2 diabetes. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of SY-008 capsules after multiple oral administration in patients with type 2 diabetes; 2) To evaluate the pharmacodynamic characteristics of SY-008 capsules after multiple oral administration in patients with type 2 diabetes.

Start Date15 Jun 2020

Sponsor / Collaborator

Suzhou Yabao Pharmaceutical R&D Co. Ltd.

[+1]

CTR20180803 / CompletedPhase 1

中国健康受试者单次口服SY-008胶囊的随机、双盲、安慰剂对照、剂量递增的耐受性及药代动力学/药效动力学试验

[Translation] A randomized, double-blind, placebo-controlled, dose-escalation study of the tolerability and pharmacokinetic/pharmacodynamic effects of a single oral dose of SY-008 capsules in healthy Chinese subjects

主要目的：评估中国健康受试者单次口服不同剂量SY-008胶囊的安全性和耐受性。次要目的：1）评估中国健康受试者单次口服不同剂量SY-008胶囊的药代动力学特征。 2）评估中国健康受试者单次口服不同剂量SY-008胶囊的药效动力学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of SY-008 capsules at different doses after a single oral administration in healthy Chinese subjects. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of SY-008 capsules at different doses after a single oral administration in healthy Chinese subjects. 2) To evaluate the pharmacodynamic characteristics of SY-008 capsules at different doses after a single oral administration in healthy Chinese subjects.

Start Date07 Aug 2018

Sponsor / Collaborator

Suzhou Yabao Pharmaceutical R&D Co. Ltd.

[+1]

100 Clinical Results associated with SY-008

100 Translational Medicine associated with SY-008

100 Patents (Medical) associated with SY-008

100 Deals associated with SY-008

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 1	CN	Suzhou Yabao Pharmaceutical R&D Co. Ltd.	02 Aug 2018
Diabetes Mellitus, Type 2	Phase 1	CN	Yabao Pharmaceutical Group Co., Ltd.	20 Mar 2018