Continuous Multiple Dose PB-119 Injection in Health Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03062774
Study type	Interventional
Source	PegBio Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	November 15, 2014
Completion date	October 8, 2016

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