Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects

Phase 1 Completed 84 enrolled Hanmi Pharmaceutical Company Limited

RandomizedSingle-groupTriple-blindTreatment

Summary

Study Design * Randomized, double-blind, placebo-controlled, escalating single-dose design. * Six ascending dose cohorts * In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control). * Primary Objective * to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.

Timeline

Start: 2009-11
Primary completion: 2011-02
Completion: 2011-04

Publications

Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eflapegrastim	Protein / enzyme biologic	1.1 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	3.3 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	10 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	45 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	135 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	270 ug/kg	Subcutaneous
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.