Clinical trial NCT03993639: KRN125 for Mobilization of Hematopoietic Stem Cells
Official title: A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Blood Stem Cell Transplantation
Keywords: Hematopoietic Stem Cells Mobilization
Healthy Volunteer (HV)
filgrastim
allogenic hematopoetic stem cell transplantation
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-21
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II, single center, open label, non-control, dose setting study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: • Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL
timeFrame: Baseline to Day 15 or through study completion, an average of 1 year
measure: • Time from baseline to peak peripheral blood CD34 positive cells
timeFrame: Baseline to Day 15 or through study completion, an average of 1 year
measure: • Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
timeFrame: Baseline to Day 7
measure: • Peripheral blood CD34 positive cell count
timeFrame: Baseline to Day 15 or through study completion, an average of 1 year
measure: • Peripheral blood white blood cell count
timeFrame: Baseline to Day 15 or through study completion, an average of 1 year
measure: • Peripheral blood neutrophil count
timeFrame: Baseline to Day 15 or through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
Study officials:
References: