KRN125 for Mobilization of Hematopoietic Stem Cells

NCT ID: NCT03993639

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2020-08-28

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.

Conditions

Peripheral Blood Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KRN125

Single SC administration

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

Single dose of SC administration

Interventions

Pegfilgrastim

Single dose of SC administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Countries

Japan

References

Goto H, Sugita J, Hasegawa Y, Hayasaka K, Sunagoya K, Hatase R, Nishida M, Ichihashi Y, Odera M, Senjo H, Yokoyama S, Ara T, Shiratori S, Endo T, Hino M, Maeda Y, Sawa M, Sato N, Teshima T. Efficacy and Safety of Single-dose Pegfilgrastim for CD34 + Cell Mobilization in Healthy Volunteers: A Phase 2 Study. Transplantation. 2024 Apr 1;108(4):996-1003. doi: 10.1097/TP.0000000000004880. Epub 2024 Mar 23.

Reference Type: DERIVED

PMID: 38012835 (View on PubMed)

Other Identifiers

125-101

Identifier Type: -

Identifier Source: org_study_id