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

Sponsor

Youngene Therapeutics Inc., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03953092

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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 Mellitus	Drug: YG1699 Drug: Placebos	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Single Ascending Dose and Multiple Ascending DoseSingle 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 1, 2019

Actual Primary Completion Date :

Nov 13, 2019

Actual Study Completion Date :

Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAD Cohort 1 5 mg YG1699 or Placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: SAD Cohort 2 10 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: SAD Cohort 3 25 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: SAD Cohort 4 50 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: SAD Cohort 5 100 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: MAD Cohort 1 5 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: MAD Cohort 2 20 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos
Experimental: MAD Cohort 3 50 mg YG1699 or placebo	Drug: YG1699 YG1699 at Multiple Doses Drug: Placebos Placebos

Outcome Measures

Primary Outcome Measures

Adverse events will be evaluated [76 Days]
Safety and Tolerability of YG1699

Secondary Outcome Measures

Area Under the Curve [AUC] [76 Days]
area under the plasma drug concentration time curve from time 0 to T (AUC)
maximum plasma concentration (Cmax) [76 days]
maximum plasma concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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;
Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
Willing and able to adhere to study restrictions and to be confined at the clinical research center.
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:

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;
An unwillingness or inability to comply with food and beverage restrictions during study participation;
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);
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frontage Labs	Secaucus	New Jersey	United States	07094

Sponsors and Collaborators

Youngene Therapeutics Inc., Ltd.

Investigators

Study Director: Yalin Li, MD, Youngene Therapeutics Inc., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Youngene Therapeutics Inc., Ltd.

ClinicalTrials.gov Identifier:

NCT03953092

Other Study ID Numbers:

YG1699 -01

First Posted:

May 16, 2019

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Youngene Therapeutics Inc., Ltd.

Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jan 11, 2021