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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01037543

Run by

Hanmi Pharmaceutical Company Limited

People needed

84

Starts

2009-11-01

Expected to finish

2011-04-01

Last updated by the study team

2014-02-07

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI of 18 - 29.9 kg/m2
• have not used tobacco or nicotine containing products for at least 3 months prior to dosing
• be able to remain abstinent throughout the study.

You may not qualify if…

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• positive urine drug/alcohol testing
• Positive for HIV, HBsAg, HCV ab
• History of anaphylactic reaction to medicine or environmental exposure

Where it is running

• Study site — California City, California, United States

Full record on ClinicalTrials.gov

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