Peripheral Blood Stem Cell Transplantation
Conditions
Keywords
Hematopoietic Stem Cells Mobilization, Healthy Volunteer (HV), filgrastim, allogenic hematopoetic stem cell transplantation
Brief summary
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
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.
Interventions
DRUGPegfilgrastim
Single dose of SC administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase II, single center, open label, non-control, dose setting study
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 | Baseline to Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| • 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 |
| • 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 |
| • 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 |
| • Peripheral blood CD34 positive cell count | Baseline to Day 15 or through study completion, an average of 1 year |
Countries
Japan
Outcome results
None listed