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

Youngene Therapeutics Inc., Ltd.1 site in 1 country64 target enrollmentMay 1, 2019

ConditionsDiabete Mellitus

InterventionsYG1699 Placebos

DrugsYG1699 Placebos

Overview

Phase: Phase 1
Intervention: YG1699
Conditions: Diabete Mellitus
Sponsor: Youngene Therapeutics Inc., Ltd.
Enrollment: 64
Locations: 1
Primary Endpoint: Adverse events will be evaluated
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

November 13, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Youngene Therapeutics Inc., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:

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;