Status:
COMPLETED
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
Lead Sponsor:
Beijing Dongfang Biotech Co., Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc. In this Double-blind, randomized, placebo-controlled trial, 41 healthy s...
Eligibility Criteria
Inclusion
- Healthy subjects
- Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m\^2
- Subjects or their legal representative signed informed consent
- agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate
- Able to keep good communication with investigator and comply with the requirements of the clinical trials
Exclusion
- Smokers,quitting time less than 3 months , or can't quit smoking during the trial
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids
- Participation in any clinical investigation within 3 months prior to dosing
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
- Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial
- A history of clinical significance of abnormal ECG
- A history of diabetes, hyperuricemia and hyperlipidemia
- A history of acute or chronic bronchial spasms
- Have clinical significant gastrointestinal diseases
- Have serious, progressive, or uncontrolled organ or system diseases
- Abuse of drug or alcohol within 12 months before first dosing
- People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group
- Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04354090
Start Date
April 26 2018
End Date
June 22 2019
Last Update
April 21 2020
Active Locations (1)
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1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008