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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Immunoglobulin Fc Fragments

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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