KRN125 for Mobilization of Hematopoietic Stem Cells

• Status: Completed
• Trial end date: 2020-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd; Kyowa Kirin Co., Ltd.

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