drugset
drugset / Trial / NCT01724814

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A

NCT01724814 ↗

Phase 1 Completed 86 enrolled Hanmi Pharmaceutical Company Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

Study Design: Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes

Timeline

Start
2012-12-20
Primary completion
2014-07-01
Completion
2014-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HM12460A Protein / enzyme biologic 1.2 unknown Subcutaneous
Subject HM12460A Protein / enzyme biologic 2.4 unknown Subcutaneous
Subject HM12460A Protein / enzyme biologic 4.8 unknown Subcutaneous
Subject HM12460A Protein / enzyme biologic 9.6 unknown Subcutaneous
Subject HM12460A Protein / enzyme biologic 14.4 unknown Subcutaneous
Subject HM12460A Protein / enzyme biologic 19.2 unknown Subcutaneous

Indications

type 1 diabetes mellitus type 2 diabetes mellitus