KRN125 for Mobilization of Hematopoietic Stem Cells

Phase 2

Completed

• Conditions: Peripheral Blood Stem Cell Transplantation
• Interventions: Drug: Pegfilgrastim

• Registration Number: NCT03993639
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study Start: 2019-05-28
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Primary Completion: 2020-07-21
• Study Completion: 2020-08-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KRN125	Pegfilgrastim	Single SC administration

Primary Outcome Measures

Name	Time	Method
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7	Baseline to Day 7

Secondary Outcome Measures

Name	Time	Method
• 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
• 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
• Time from baseline to peak peripheral blood CD34 positive cells	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

Trial Locations

Locations (1)

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan