A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699

NCT03953092 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: YG1699 -01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.

Conditions

Diabete Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Adverse events will be evaluated

  Safety and Tolerability of YG1699

  76 Days

Secondary Outcomes (2)

• Area Under the Curve [AUC]

  76 Days

• maximum plasma concentration (Cmax)

  76 days

Study Arms (8)

SAD Cohort 1

EXPERIMENTAL

5 mg YG1699 or Placebo

Drug: YG1699; Drug: Placebos

SAD Cohort 2

EXPERIMENTAL

10 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

SAD Cohort 3

EXPERIMENTAL

25 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

SAD Cohort 4

EXPERIMENTAL

50 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

SAD Cohort 5

EXPERIMENTAL

100 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

MAD Cohort 1

EXPERIMENTAL

5 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

MAD Cohort 2

EXPERIMENTAL

20 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

MAD Cohort 3

EXPERIMENTAL

50 mg YG1699 or placebo

Drug: YG1699; Drug: Placebos

Interventions

YG1699 DRUG

YG1699 at Multiple Doses

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Placebos DRUG

Placebos

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

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 -1, 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 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;
• Normal renal function with estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or greater and as deemed by the Investigator;
• Non-smoker and no more than 2 tobacco-containing including nicotine replacement products in last 6 months;

You may not qualify if:

• 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;
• Known or suspected malignancy;
• History of pancreatitis or gall stones;
• History of unexplained syncope, symptomatic hypotension or hypoglycemia;
• Family history of long 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), or hepatitis C 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, or illicit drug use within 9 months prior to screening;
• A history of alcohol abuse according to medical history within 9 months prior to screening;
• A positive screen for alcohol, drugs of abuse at screening or Day -1;

Sponsors & Collaborators

• Youngene Therapeutics Inc., Ltd.: lead

Study Sites (1)

Frontage Labs

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Yalin Li, MD

  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 Ascending Dose

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: May 1, 2019
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)