Trials / Unknown
UnknownNCT02971722
a Study of JY09 in Chinese Healthy Subjects
Randomized,Double-blind,Placebo-controlled,Dose-escalating Phase I,Healthy Subjects Study of JY09,a Recombinant GLP-1 Receptor Agonist
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- Beijing Dongfang Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JY09 | 2mg/1ml/bottle |
| DRUG | Placebo | 1ml/bottle |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-05-01
- Completion
- 2018-03-01
- First posted
- 2016-11-23
- Last updated
- 2016-12-07
Source: ClinicalTrials.gov record NCT02971722. Inclusion in this directory is not an endorsement.