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

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ClinicalTrials.gov Identifier: NCT03953092
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Youngene Therapeutics Inc., Ltd.

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.

Condition or disease Intervention/treatment Phase
Diabete Type 2 Drug: YG1699 Drug: Placebo Phase 1

Detailed Description:

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.

The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single Ascending Dose and Multiple Ascending Dose
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blinded
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAD Cohort 1
5 mg YG1699 or Placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: SAD Cohort 2
10 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: SAD Cohort 3
25 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: SAD Cohort 4
50 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: SAD Cohort 5
100 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: MAD Cohort 1
10 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: MAD Cohort 2
25 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo

Experimental: MAD Cohort 3
50 mg YG1699 or placebo
Drug: YG1699
YG1699 at Multiple Doses

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Adverse events will be evaluated [ Time Frame: 76 Days ]
    Safety and Tolerability of YG1699


Secondary Outcome Measures :
  1. Area Under the Curve [AUC] [ Time Frame: 76 Days ]
    area under the plasma drug concentration time curve from time 0 to T (AUC)

  2. maximum plasma concentration (Cmax) [ Time Frame: 76 days ]
    maximum plasma concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -1, 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 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. Normal renal function with estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or greater and as deemed by the Investigator;
  6. Non-smoker and no more than 2 tobacco-containing including nicotine replacement products in last 6 months;
  7. Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
  8. Willing and able to adhere to study restrictions and to be confined at the clinical research center.
  9. 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. 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;
  2. Known or suspected malignancy;
  3. History of pancreatitis or gall stones;
  4. History of unexplained syncope, symptomatic hypotension or hypoglycemia;
  5. Family history of long QTc syndrome;
  6. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
  7. Poor venous access;
  8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
  9. Donated or lost >500ml of blood in the previous 3 months;
  10. Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives), whichever is longer;
  11. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
  12. Hospital admission or major surgery within 6 months prior to screening;
  13. A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
  14. A history of alcohol abuse according to medical history within 9 months prior to screening;
  15. A positive screen for alcohol, drugs of abuse at screening or Day -1;
  16. An unwillingness or inability to comply with food and beverage restrictions during study participation;
  17. Use of over-the-counter (OTC) medication within 7 days, and herbal (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953092


Contacts
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Contact: Karen Kang, Pharm D 201-416-7779 wkang@frontagelab.com

Locations
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United States, New Jersey
Frontage Labs Recruiting
Secaucus, New Jersey, United States, 07094
Contact: Karen Kang, PharmD    201-416-7773    wkang@frontagelab.com   
Principal Investigator: Sumitha Reddy, MD         
Sponsors and Collaborators
Youngene Therapeutics Inc., Ltd.

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Responsible Party: Youngene Therapeutics Inc., Ltd.
ClinicalTrials.gov Identifier: NCT03953092     History of Changes
Other Study ID Numbers: YG1699 -01
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Youngene Therapeutics Inc., Ltd.:
Diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases