a Study of JY09 in Chinese Healthy Subjects

NCT ID: NCT02971722

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-03-31

Brief Summary

JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09 exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose covering and islet cell recovering,as well as good tolerance and safety.JY09 has been approved by China food and drug administration(CFDA) to enter the clinical research stage(Grant number 2016L04254).This study is designed to assess the safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in healthy Chinese volunteers.

Conditions

Healthy

Keywords

GLP-1 receptor agonist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.3mg JY09(cohort 1)

0.3mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

1.5mg JY09(cohort 1)

1.5mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

6.0mg JY09(cohort 1)

6.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

Placebo(cohort 1)

Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1ml/bottle

0.7mg JY09(cohort2)

0.7mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

3.0mg JY09(cohort2)

3.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

12.0mg JY09(cohort2)

12.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

2mg/1ml/bottle

Placebo(cohort 2)

Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1ml/bottle

Interventions

JY09

2mg/1ml/bottle

Intervention Type: DRUG

Placebo

1ml/bottle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects.
• Male's mass is equal or greater than 50 kg, female's mass is equal or greater than 45 kg,have a body mass index (BMI) between 18 and 28 kilograms per square meter (kg/m^2), inclusive.
• The subjects sign informed consent form voluntarily.
• The subjects 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.
• Participants will be able to keep good communication with investigator and comply with the requirements of the clinical trials

Exclusion Criteria

• 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 or family history of long QT syndrome (grandparents, parents and siblings)
• Have a family history of diabetes (grandparents, parents and siblings).
• Have a history of acute or chronic bronchial spasms(including after treatment or no treatment of asthma and chronic obstructive pulmonary disease )
• Have a history of drug allergy or atopic disease allergy(asthma, urticaria, eczema, dermatitis),or allergy history of trail drugs or similar drugs.
• Have gastrointestinal diseases,such as history of liver disease, gastrointestinal disease,gastrointestinal surgery (appendix removed except) or chronic pancreatitis, or history of idiopathic acute pancreatitis that,in the opinion of the investigator,is clinical significant.
• Have personal or family history of medullary thyroid cancer (MTC) or a hereditary disease that induce MTC .
• Have a history of immunodeficiency disease,including human immunodeficiency virus (HIV) antibody positive.
• Have a history of needlesickness that,in the opinion of the investigator,is clinical significant.
• Have an unknown cause of infection.
• In screening,any abnormal results of physical examination, vital signs,electrocardiogram (ECG) and clinical laboratory that,in the opinion of the investigator,is clinical significant.
• Hepatitis b surface antigen or hepatitis c antibody positive, or treponema pallidum antibody positive.
• Abuse of drug or alcohol within 12 months before first dosing,or in screening found evidence of abuse in laboratory tests.
• People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group.
• In screening,lying position (after 3 minutes rest) systolic blood pressure outside the range 90 ~ 140 MMHG, or diastolic blood pressure outside the range 50-90 MMHG, or pulse (HR) outside the range 40 ~ 100 bpm, boundary value into the group.
• Have chang of weight > 3 kg within 3 months by self-report.
• Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Dongfang Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice. J Pharmacol Exp Ther. 2003 Nov;307(2):490-6. doi: 10.1124/jpet.103.051987. Epub 2003 Sep 15.

Reference Type: BACKGROUND

PMID: 12975499 (View on PubMed)

Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.

Reference Type: BACKGROUND

PMID: 20152707 (View on PubMed)

Other Identifiers

DFBT-JY09-1

Identifier Type: -

Identifier Source: org_study_id