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

January 25, 2022 updated by: Youngene Therapeutics Inc., Ltd.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Shanghai Xinhua hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAD Cohort 1
5 mg YG1699 or Placebo

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

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

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
Time Frame: 81 Days
Safety and Tolerability of YG1699
81 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve [AUC]
Time Frame: 81 Days
area under the plasma drug concentration time curve from time 0 to T (AUC)
81 Days
maximum plasma concentration (Cmax)
Time Frame: 81 Days
maximum plasma concentration
81 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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