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

Study Overview
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Brief Summary
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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.

Detailed Description
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Secondary objectives: to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A. to compare the PK of HM10460A in Japanese and Caucasian subjects. to assess the relationship between the serum concentration of HM10460A and absolute neutrophil count (ANC). to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood. To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.

Official Title
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A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: HM10460A or placebo or Neulasta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>1.1 mcg/kg of HM10460A, placebo, or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|
| Experimental: Cohort 2<br>3.3 mcg/kg HM10460A, placebo or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|
| Experimental: Cohort 3<br>10 mcg/kg of HM10460A, placebo, or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|
| Experimental: Cohort 4<br>30 mcg/kg of HM10460A, placebo, or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|
| Experimental: Cohort 5<br>90 mcg/kg or HM10460A, placebo, or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|
| Experimental: Cohort 6<br>270 mcg/kg of HM10460A, placebo, or Neulasta | Drug: HM10460A or placebo or Neulasta<br>* Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.<br>* Other names: LAPS-G-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs). |  | Time points where appropriate. | 
| Samples for immunogenicity |  | Days -1, 15, 22, and 42. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters measured from Serum and Urine samples. |  | Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose. | 
| Calculation of ANC and CD34+ cell counts. |  | pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22. |