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

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04082091` - Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
Active, not recruiting	`NCT02248311` - "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population	N/A
Completed	`NCT02653300` - A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)	Phase 2
Completed	`NCT03655535` - Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes	Phase 2
Completed	`NCT03256747` - Effects of Neuromuscular Electrical Stimulation on Glucose Variability in Patients With Type 2 Diabetes	N/A
Withdrawn	`NCT03675074` - Neujia Anastomosis for Treatment of Obesity and Type II Diabetes	N/A
Completed	`NCT05343767` - Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus	N/A
Withdrawn	`NCT03190798` - Effects of Canagliflozin on Intravascular Volume and Hemodynamics	Phase 4
Withdrawn	`NCT03437330` - Empagliflozin Effect on Glucose Toxicity	Phase 4
Withdrawn	`NCT03008395` - Empowerment, Motivation and Medical Adherence (EMMA).	N/A
Not yet recruiting	`NCT05539066` - AI Health Assistant and Type 2 Diabetes	N/A
Completed	`NCT03682445` - Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus	N/A
Not yet recruiting	`NCT03239119` - The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus	Phase 3
Completed	`NCT03259789` - Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects	Phase 3
Recruiting	`NCT03506230` - Financial Incentives for Low Socioeconomic Diabetic Patients	N/A
Completed	`NCT03072407` - MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM	Phase 1
Completed	`NCT05668442` - Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes
Completed	`NCT02964572` - Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes	N/A
Completed	`NCT02956044` - Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin	Phase 1
Completed	`NCT02628392` - A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)	N/A