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This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | 5 mg YG1699 or Placebo |
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| SAD Cohort 2 | Experimental | 25 mg YG1699 or Placebo |
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| Multiple Doses Cohort 1 | Experimental | 20 mg YG1699 or Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YG1699 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events will be evaluated | Safety and Tolerability of YG1699 | 81 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve [AUC] | area under the plasma drug concentration time curve from time 0 to T (AUC) | 81 Days |
| maximum plasma concentration (Cmax) | maximum plasma concentration |
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Inclusion Criteria:
Are capable of giving informed consent and complying with study procedures;
Are between the ages of 18 and 55 years, inclusive;
Female subjects have a negative urine pregnancy test result at screening and Day 0, and meet one of the following criteria:
Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
Surgically sterile for at least 3 months prior to screening by one of the following means:
Bilateral tubal ligation Bilateral salpingectomy (with or without oophorectomy) Surgical hysterectomy Bilateral oophorectomy (with or without hysterectomy)
Postmenopausal, defined as the following:
Last menstrual period greater than 12 months prior to screening Postmenopausal status confirmed by serum Follicle-Stimulating Hormone(FSH) and estradiol levels at screening;
Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
Non-smoker and less than 5 cigarettes/day or nicotine replacement products in last 6 months;
Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
Male subjects with female partners of child bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiaojuan He, Master | Youngene Therapeutics Inc., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xinhua Hospital | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Single Ascending Dose and Multiple Dose
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Double Blinded
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| 81 Days |