NCT03062774

Continuous Multiple Dose PB-119 Injection in Health Volunteers

The Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Continuous Multiple Dose PB-119 Injection in Health Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	PB-119 injection

Timeline

• Start date: 2014-11-15
• Primary completion: 2016-09-13
• Completion: 2016-10-08
• First posted: 2017-02-23
• Last updated: 2017-02-23

Locations

1 site across 1 country: China