| Trial ID: | L6157 |
| Source ID: | NCT03745885
|
| Associated Drug: |
Supaglutide Injection
|
| Title: |
A Study of the Efficacy and Safety of Supaglutide in Healthy Participants
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Supaglutide injection|DRUG: Placebo
|
| Outcome Measures: |
Primary: Pharmacokinetic：Cmax of Supaglutide, Maximum Concentration(Cmax) of Supaglutide, baseline and up to 29 days after formal dose|Pharmacokinetic: Tmax of Supaglutide, Time to maximum plasma concentration (Tmax), baseline and up to 29 days after formal dose|Pharmacokinetic: AUC0-t of Supaglutide, Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t), baseline and up to 29 days after formal dose|Pharmacokinetic: t½ of Supaglutide, Terminal elimination half-life in plasma (t½), baseline and up to 29 days after formal dose |
|
| Sponsor/Collaborators: |
Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-12-04
|
| Completion Date: |
2019-12-13
|
| Results First Posted: |
|
| Last Update Posted: |
2021-09-17
|
| Locations: |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03745885
|
