a Study of JY09 in Chinese Healthy Subjects

NCT02971722 | Unknown Phase 1

• 1 other identifier: DFBT-JY09-1
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK)

  Area Under the Concentration Versus Time Curve (AUC) of JY09

  Baseline through day29 of period

Secondary Outcomes (3)

• immunogenicity

  Baseline through day29 of period

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  baseline to 3 months(cohort1 and cohort 2)

• Pharmacodynamics (PD）

  Baseline through day29 of period

Study Arms (8)

0.3mg JY09(cohort 1)

EXPERIMENTAL

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

Drug: JY09

1.5mg JY09(cohort 1)

EXPERIMENTAL

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

Drug: JY09

6.0mg JY09(cohort 1)

EXPERIMENTAL

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

Drug: JY09

Placebo(cohort 1)

PLACEBO COMPARATOR

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

Drug: Placebo

0.7mg JY09(cohort2)

EXPERIMENTAL

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

Drug: JY09

3.0mg JY09(cohort2)

EXPERIMENTAL

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

Drug: JY09

12.0mg JY09(cohort2)

EXPERIMENTAL

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

Drug: JY09

Placebo(cohort 2)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JY09 DRUG

2mg/1ml/bottle

0.3mg JY09(cohort 1); 0.7mg JY09(cohort2); 1.5mg JY09(cohort 1); 12.0mg JY09(cohort2); 3.0mg JY09(cohort2); 6.0mg JY09(cohort 1)

Placebo DRUG

1ml/bottle

Placebo(cohort 1); Placebo(cohort 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Dongfang Biotech Co., Ltd.: lead

Related Publications (2)

• 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.

  PMID: 12975499 BACKGROUND

• 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.

  PMID: 20152707 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2018
• Last Updated: December 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share