NCT03072407

MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.

Detailed description

Dose levels of 25 µg, 50 µg, 100 µg and 200 µg with a dosing regimen of once weekly for 4 consecutive weeks will be evaluated

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	PB-119 injection
BIOLOGICAL	PB-119 injection placebo

Timeline

• Start date: 2015-11-24
• Primary completion: 2016-11-02
• Completion: 2016-11-15
• First posted: 2017-03-07
• Last updated: 2018-04-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study