Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, 200092, China
NCT Number: NCT05089617
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200092, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Bilateral tubal ligation Bilateral salpingectomy (with or without oophorectomy) Surgical hysterectomy Bilateral oophorectomy (with or without hysterectomy)
Last menstrual period greater than 12 months prior to screening Postmenopausal status confirmed by serum Follicle-Stimulating Hormone(FSH) and estradiol levels at screening;
Exclusion criteria
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.
Time frame: 81 Days
Safety and Tolerability of YG1699
Time frame: 81 Days
area under the plasma drug concentration time curve from time 0 to T (AUC)
Time frame: 81 Days
maximum plasma concentration
Youngene Therapeutics Inc., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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