drugset / Trial / NCT02971722
a Study of JY09 in Chinese Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2016-12
- Primary completion
- 2017-05
- Completion
- 2018-03
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JY09 | Protein / enzyme biologic | 0.3 mg | Subcutaneous |
| Subject | JY09 | Protein / enzyme biologic | 0.7 mg | Subcutaneous |
| Subject | JY09 | Protein / enzyme biologic | 1.5 mg | Subcutaneous |
| Subject | JY09 | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | JY09 | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Subject | JY09 | Protein / enzyme biologic | 12 mg | Subcutaneous |
Indications
No indication recorded.