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This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will be performed at the same time with tolerability study. Three dose arms are designed, 12 subjects will be enrolled in each arm, will equal number of males and females.
Pharmacokinetic and pharmacodynamics studies were performed in parallel with PB-119 25μg、50μg、and 100μg dose escalation tolerability study, plasma samples were collected to determine drug concentration and pharmacodynamics parameters. The study duration of each arm was 8 weeks, study medication was given about 8:00 a.m. on day 1 of each week, totally 6 times, and subject was followed until 15 days after last dose (50 days of study) and then study can be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB-119 | Experimental | intervention: PB-119 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PB-119 injection | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | Change from Baseline lab value at 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine PB-119 blood concentration | Number of PB-119 blood concentration | Day1-8, Day 15, Day 22, Day 29, Day 36-42, Day 46,Day 50, Day 54 and Day 58 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan LV | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33576936 | Derived | Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Ma XZ, Xia YH, Tian JH, Ma Y, Liu Y, Zhang P, Xu M. Safety, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Doses of PEGylated Exenatide (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):265-275. doi: 10.1007/s13318-020-00665-x. Epub 2021 Feb 12. |
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