Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3mg JY09(cohort 1) | Experimental | 0.3mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| 1.5mg JY09(cohort 1) | Experimental | 1.5mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| 6.0mg JY09(cohort 1) | Experimental | 6.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| Placebo(cohort 1) | Placebo Comparator | Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| 0.7mg JY09(cohort2) | Experimental | 0.7mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| 3.0mg JY09(cohort2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JY09 | Drug | 2mg/1ml/bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | Area Under the Concentration Versus Time Curve (AUC) of JY09 | Baseline through day29 of period |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity | A measure of the body's immune response to JY09 | Baseline through day29 of period |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | Weight loss of subject is greater than 3 kg will be recorded as adverse events in a month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12975499 | Background | 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. | |
| 20152707 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
3.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| 12.0mg JY09(cohort2) | Experimental | 12.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| Placebo(cohort 2) | Placebo Comparator | Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods |
|
| Placebo | Drug | 1ml/bottle |
|
| baseline to 3 months(cohort1 and cohort 2) |
| Pharmacodynamics (PD) | Area Under the Concentration Versus Time Curve (AUC) of Glucose | Baseline through day29 of period |