KRN125 for Mobilization of Hematopoietic Stem Cells

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Blood Stem Cell Transplantation
• Intervention / Treatment: Drug: Pegfilgrastim

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Hokkaido University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KRN125; Single SC administration	Drug: Pegfilgrastim; Single dose of SC administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): August 28, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hematopoietic Stem Cells Mobilization; Healthy Volunteer (HV); filgrastim; allogenic hematopoetic stem cell transplantation
• Other Study ID Numbers: 125-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No