KRN125 for Mobilization of Hematopoietic Stem Cells

Study Overview
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Brief Summary
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Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.

Detailed Description
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KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.

Official Title
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A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers

Conditions
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Peripheral Blood Stem Cell Transplantation

Intervention / Treatment
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* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese subjects aged 20 to 55 years or younger at the submission of the written informed consent form Women weighing 40 kg or more and 80 kg or less and men weighing 45 kg or more and 80 kg or less at the time of the preliminary examination Exclusion Criteria: Subjects with a current medical history or who have been judged to be inappropriate for the study (e.g., significant neurological, hepatic, renal, endocrine, cardiovascular, blood, gastrointestinal, respiratory, and metabolic diseases, malignancies, myeloproliferative disorder, or psychiatric disorders) Individuals with alcohol or drug dependence, or individuals who have not tested negative for all drugs of abuse in the preliminary test Subjects with a history or current history of drug allergy or symptomatic allergy .Active infection or history of recurrent infection- However, only patients who are HBsantibody-positive by hepatitis B vaccination and whose HBV-DNA is less than the lower limit of quantitation will be allowed to participate in this study. Subjects who used drugs within 2 weeks before administration of the investigational drug. Subjects who have had at least 200 mL of blood drawn within 3 months before administration of the investigational drug. Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Interventional Model Description: Phase II, single center, open label, non-control, dose setting study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN125<br>Single SC administration | Drug: Pegfilgrastim<br>* Single dose of SC administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 |  | Baseline to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL |  | Baseline to Day 15 or through study completion, an average of 1 year | 
| • Time from baseline to peak peripheral blood CD34 positive cells |  | Baseline to Day 15 or through study completion, an average of 1 year | 
| • Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 |  | Baseline to Day 7 | 
| • Peripheral blood CD34 positive cell count |  | Baseline to Day 15 or through study completion, an average of 1 year | 
| • Peripheral blood white blood cell count |  | Baseline to Day 15 or through study completion, an average of 1 year | 
| • Peripheral blood neutrophil count |  | Baseline to Day 15 or through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cells Mobilization, Healthy Volunteer (HV), filgrastim, allogenic hematopoetic stem cell transplantation