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

NCT03072407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Type2 Diabetes Mellitus

Interventions

BIOLOGICAL

PB-119 injection

BIOLOGICAL

PB-119 injection placebo

Sponsors & Collaborators

  • PegBio Co., Ltd.

    lead OTHER

Principal Investigators

  • Gregory Tracey, Dr. · Frontage Clinical Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-24
Primary Completion
2016-11-02
Completion
2016-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072407 on ClinicalTrials.gov