To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects

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

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: YG1699

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Shen, Docotor; Phone Number: 13301788623; Email: joanshenwei@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Shanghai Xinhua hospital
      • Contact: Wei Shen, Doctor; Phone Number: 13301788623; Email: joanshenwei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are capable of giving informed consent and complying with study procedures;
2. Are between the ages of 18 and 55 years, inclusive;

3. Female subjects have a negative urine pregnancy test result at screening and Day 0, and meet one of the following criteria:

   1. 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)]

   2. 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)

   3. 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;

4. Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
5. Non-smoker and less than 5 cigarettes/day or nicotine replacement products in last 6 months;
6. Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
7. 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:

1. Subjects of non-Chinese nationality living or working in China, or persons of non-East Asian descent who are Chinese nationals;
2. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
3. History of food or drug allergy;
4. Known or suspected malignancy;
5. History of unexplained syncope, symptomatic hypotension or hypoglycemia;
6. History or family history of long corrective QT interval（QTc） syndrome;
7. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
8. Poor venous access;
9. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibody or treponema pallidum antibody ;
10. Donated or lost >500ml of blood in the previous 3 months;
11. Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives), whichever is longer;
12. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
13. Hospital admission or major surgery within 6 months prior to screening;
14. A history of prescription drug abuse within 9 months prior to screening;
15. A history of alcohol abuse according to medical history within 9 months prior to screening;
16. Female subjects with positive pregnancy test, pregnant or breastfeeding;
17. A positive screen for alcohol, drugs of abuse at screening;
18. An unwillingness or inability to comply with food and beverage restrictions during study participation;
19. Use of over-the-counter (OTC) medication and herbal within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
20. Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohort 1; 5 mg YG1699 or Placebo	Drug: YG1699; 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.
Experimental: SAD Cohort 2; 25 mg YG1699 or Placebo	Drug: YG1699; 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.
Experimental: Multiple Doses Cohort 1; 20 mg YG1699 or Placebo	Drug: YG1699; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events will be evaluated	Safety and Tolerability of YG1699	81 Days

Secondary Outcome Measures

Outcome Measure	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	81 Days

Collaborators and Investigators

• Sponsor: Youngene Therapeutics Inc., Ltd.
• Investigators: Study Director: Jiaojuan He, Master, Youngene Therapeutics Inc., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2022
• Primary Completion (Anticipated): March 21, 2022
• Study Completion (Anticipated): May 5, 2022

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes
• Other Study ID Numbers: YG1699-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No