Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
Condition: Healthy Participants
Intervention: Tbo-filgrastim
Intervention description: solution for subcutaneous injection
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of
      10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on
      the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male
      and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and
      immunogenicity of tbo-filgrastim will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent is obtained from the participant

          -  The participant has a body weight of at least 50 kilograms (kg)

          -  The participant has a body mass index (BMI) of more than 18.5 and less than 35.0
             kilograms per square meter (kg/m^2)

          -  The participant is in good health as determined by medical and psychiatric history,
             physical examination, electrocardiogram (ECG) recordings, serum chemistry, hematology,
             coagulation, urinalysis, and serology

          -  Women may be included only if they have a negative beta human chorionic gonadotropin
             (beta-hCG) test at baseline, are sterile (defined as documented hysterectomy,
             bilateral oophorectomy or bilateral salpingectomy, or congenitally sterile), or
             postmenopausal (defined as no menses for 12 months without alternative medical cause
             and increased follicle stimulating hormone [FSH] of above 35 units per liter [U/L] in
             women not using hormonal contraception or hormonal replacement therapy). Women of
             childbearing potential whose male partners are potentially fertile (that is, no
             vasectomy) must use highly effective birth control methods for the duration of the
             study and for 30 days after the last tbo-filgrastim administration

          -  The participant has a negative alcohol urine test and a negative urine drug screen

          -  The participant must be willing and able to comply with study restrictions

          -  The participant is human leukocyte antigen (HLA) -matched or haploidentical-related to
             the recipient

        Exclusion Criteria:

          -  The participant currently has or had a history of any clinically relevant
             gastrointestinal, hematologic, respiratory, psychiatric, renal, hepatic, cardiac,
             metabolic (such as, fructose intolerance), neurological, or any other disease or
             condition which may influence the physiological metabolic turnover (such as, severe
             endocrine diseases, febrile condition, severe infections), which may interfere with
             the study objectives, or which could expose the participant to undue risk through the
             participation in the clinical study

          -  The participant has had: (1) a trauma or surgery in the past 2 months; (2) a
             clinically relevant illness within 4 weeks before the first dose of tbo-filgrastim;
             (3) any acute illness within 1 week before the first dose of tbo-filgrastim; or (4)
             symptoms of any clinically relevant or acute illness at baseline

          -  The participant has existence or recent history of persistent pulmonary infiltrates,
             recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence
             of any lung disease including asthma, or current symptoms of upper respiratory tract
             infection. In the case of pneumonia, participant may be screened 12 weeks after
             cessation of antibiotic treatment

          -  The participant has findings of splenomegaly on sonography at screening, defined by
             length of spleen more than 12.3 centimeters (cm) and clinical judgment

          -  The participant has a history of malignancy, including hematologic malignancy, except
             for appropriately treated non-melanoma skin carcinoma in the last 5 years

          -  The participant has a clinically significant deviation from normal in ECG recordings
             or physical examination findings, as determined by the investigator

          -  The participant is pregnant or lactating, or was pregnant in the previous 6 months, or
             intends to get pregnant during the study or within 30 days after the last dose of
             study drug

          -  The participant has habitually consumed, within the last 2 years, more than 21 units
             of alcohol per week, or has a history or evidence of alcohol, narcotic, or any other
             substance abuse as defined by the Diagnostic and Statistical Manual of Mental
             Disorder, Fifth Edition (DSM-V, American Psychiatric Association 2013). Note: A unit
             of alcohol is equal to 1 ounce (29.6 milliliters [mL]) of hard liquor, 5 ounces (148
             mL) of wine, or 8 ounces (236.8 mL) of beer

          -  The participant has taken any of the following investigational medicinal products
             (IMPs), medicinal products, or substances:

               1. Any IMP within 30 days or 5 half-lives (whichever is longer) before the first
                  dose of tbo-filgrastim, or in the case of a new chemical entity, 3 months or 5
                  half-lives (whichever is longer) before the first dose of tbo-filgrastim

               2. Known history of treatment with blood-cell colony-stimulating factors

               3. Current or recent (within 4 weeks) treatment with lithium

          -  The participant has donated plasma within 7 days before screening or has donated blood
             within 56 days before screening

          -  The participant has a documented or self-reported history of tuberculosis or recent
             travel to countries of endemic disease (last 8 weeks)

          -  The participant has 1 or more clinical laboratory test value(s) outside the range
             specified below, or any other clinically significant laboratory abnormality as
             determined by the investigator or medical monitor:

               1. Hemoglobin less than or equal to (<=) 12.5 grams per deciliter (g/dL) (women) and
                  hemoglobin <=13.5 g/dL (men)

               2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values of
                  greater than (>) 3 * the upper limit of the normal range (ULN)

               3. Total bilirubin of >2 * ULN

               4. Findings of cholestasis (eg, abnormal values of alkaline phosphatase)

          -  The participant has a positive test result for human immunodeficiency virus (HIV),
             hepatitis B surface antigen, antibodies to hepatitis C virus, immunoglobulin M (IgM)
             antibodies to cytomegalovirus, human T-lymphotropic virus, West Nile virus, malaria,
             or syphilis

          -  The participant has a documented or self-reported history of tuberculosis or recent
             travel to countries of endemic disease (last 8 weeks)

          -  The participant has, after resting for 5 minutes, increased blood pressure (BP)
             (defined as systolic BP in seated position of more than 145 millimeters of mercury [mm
             Hg] or diastolic BP in seated position of more than 95 mm Hg), or low BP (defined as
             systolic BP in seated position of less than 90 mm Hg or diastolic BP in seated
             position of less than 45 mm Hg) (Only 2 rechecks of the participant's BP are permitted
             for eligibility purposes)

          -  The participant has, after resting for 5 minutes, a pulse in seated position of less
             than 45 or more than 90 beats per minute (Only 2 rechecks of the participant's pulse
             are permitted for eligibility purposes)

          -  The participant is unwilling to refrain from vigorous exercise (eg, strenuous or
             unaccustomed weight lifting, running, bicycling) from 72 hours before Day 1 until Day
             15

          -  The participant is unlikely to comply with the study protocol or is unsuitable for any
             other reasons, as judged by the investigator

          -  The participant has a history of autoimmune disease, including rheumatic diseases and
             thyroid disorders

          -  The participant has a history of deep vein thrombosis or pulmonary embolism

          -  The participant has thrombocytopenia defined as platelet count <150 * 109 cells per
             liter (cells/L) at screening or at baseline

          -  The participant has a history of bleeding problems (eg, hemophilia, thrombocytopenia,
             idiopathic thrombocytopenic purpura, clotting factor deficiencies or disorders)

          -  The participant has positive hemoglobin-solubility test

          -  The participant has a history of iritis or episcleritis

          -  The participant has a history of significant hypersensitivity, intolerance, or allergy
             to tbo-filgrastim or any other E. coli derived product or excipient, or other
             medicinal product, food, or substance, unless approved by the investigator