KRN125 for Mobilization of Hematopoietic Stem Cells

Peripheral Blood Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993639
• Other study ID #: 125-101
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2019
• Est. completion date: August 28, 2020

Study information

• Verified date: January 2021
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 28, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Blood Stem Cell Transplantation

Intervention

Drug:
• Pegfilgrastim
Single dose of SC administration

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of >20 cells/µL positive for CD34 in peripheral blood from baseline to Day 7		Baseline to Day 7
Secondary	• 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
Secondary	• Time from baseline to peak peripheral blood CD34 positive cells		Baseline to Day 15 or through study completion, an average of 1 year
Secondary	• Achievement of >10 cells/µL positive for CD34 in peripheral blood from baseline to Day 7		Baseline to Day 7
Secondary	• Peripheral blood CD34 positive cell count		Baseline to Day 15 or through study completion, an average of 1 year
Secondary	• Peripheral blood white blood cell count		Baseline to Day 15 or through study completion, an average of 1 year
Secondary	• Peripheral blood neutrophil count		Baseline to Day 15 or through study completion, an average of 1 year