| Trial ID: | L5215 |
| Source ID: | NCT04354090
|
| Associated Drug: |
Jy09
|
| Title: |
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: JY09
|
| Outcome Measures: |
Primary: Incidence of adverse events and serious adverse events related to JY09, Up to day 21 | Secondary: Pharmacodynamics parameters: Cmax, Average Cmax of each dose level, Up To day 42|Pharmacodynamics parameters: AUC, Average AUC follewing single dose of each doase level, Up to day 42|Pharmacodynamics parameters: Half-life, Average Half-life of each dose level, Up to day 42|Pharmacokinetics parameters, OGTT test was conducter predose and 5 days after the target dose in each cohorts, Day 5|Immunogenicity, Anti-JY09 antibody incidence at each dose level, Up To day 42
|
| Sponsor/Collaborators: |
Sponsor: Beijing Dongfang Biotech Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2018-04-26
|
| Completion Date: |
2019-06-22
|
| Results First Posted: |
|
| Last Update Posted: |
2020-04-21
|
| Locations: |
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04354090
|
