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

NCT05089617 | Completed Phase 1 FDA Drug

• 1 other identifier: YG1699-102
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Adverse events will be evaluated

  Safety and Tolerability of YG1699

  81 Days

Secondary Outcomes (2)

• Area Under the Curve [AUC]

  81 Days

• maximum plasma concentration (Cmax)

  81 Days

Study Arms (3)

SAD Cohort 1

EXPERIMENTAL

5 mg YG1699 or Placebo

Drug: YG1699

SAD Cohort 2

EXPERIMENTAL

25 mg YG1699 or Placebo

Drug: YG1699

Multiple Doses Cohort 1

EXPERIMENTAL

20 mg YG1699 or Placebo

Drug: YG1699

Interventions

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.

Multiple Doses Cohort 1; SAD Cohort 1; SAD Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects of non-Chinese nationality living or working in China, or persons of non-East Asian descent who are Chinese nationals;
• 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;
• History of food or drug allergy;
• Known or suspected malignancy;
• History of unexplained syncope, symptomatic hypotension or hypoglycemia;
• History or family history of long corrective QT interval（QTc） syndrome;
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
• Poor venous access;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibody or treponema pallidum antibody ;
• Donated or lost \>500ml of blood in the previous 3 months;
• Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives), whichever is longer;
• Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
• Hospital admission or major surgery within 6 months prior to screening;
• A history of prescription drug abuse within 9 months prior to screening;
• A history of alcohol abuse according to medical history within 9 months prior to screening;

Sponsors & Collaborators

• Youngene Therapeutics Inc., Ltd.: lead

Study Sites (1)

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jiaojuan He, Master

  Youngene Therapeutics Inc., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose and Multiple Dose

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 22, 2021
• Study Start: January 9, 2022
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: January 31, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)