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drugset / Trial / NCT01093742

A Study of HM10560A in Healthy Male Subject

NCT01093742 ↗

Phase 1 Completed 32 enrolled Hanmi Pharmaceutical Company Limited
RandomizedSingle-groupTriple-blindTreatment

Summary

* Study Design * Randomized, Double-blind, Placebo-controlled, escalating single-dose design. * Four ascending dose cohorts. * In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control). * Objectives * The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

Timeline

Start
2010-03
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject HM10560A Protein / enzyme biologic 0.089 mg/kg Subcutaneous
Subject HM10560A Protein / enzyme biologic 0.179 mg/kg Subcutaneous
Subject HM10560A Protein / enzyme biologic 0.357 mg/kg Subcutaneous
Subject HM10560A Protein / enzyme biologic 0.714 mg/kg Subcutaneous

Indications

No indication recorded.