drugset / Trial / NCT01972893

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers

NCT01972893 ↗

Phase 1 Completed 56 enrolled Zydus Lifesciences Limited
RandomizedParallel-groupTriple-blindTreatment

Summary

ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic cleavage, especially against dipeptidyl peptidase-4 (DPP-IV). ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.

Timeline

Start
2011-02
Primary completion
2012-03
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ZYD1 Unknown 0.5 mg Subcutaneous
Subject ZYD1 Unknown 1 mg Subcutaneous
Subject ZYD1 Unknown 2 mg Subcutaneous
Subject ZYD1 Unknown 5 mg Subcutaneous
Subject ZYD1 Unknown 10 mg Subcutaneous
Subject ZYD1 Unknown 25 mg Subcutaneous
Subject ZYD1 Unknown 50 mg Subcutaneous