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This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Placebo Comparator | Placebo or 2.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. |
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| Cohort 2 | Placebo Comparator | Placebo or 4.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imprime PGG TM for Injection | Biological | Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| -To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG | Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| -To evaluate the progenitor cell mobilizing efficacy of Imprime PGG when dosed as part of a standard 4-day progenitor cell mobilizing regimen of G-CSF assessed through peripheral blood CD34+ cell counts | Prospective |
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Inclusion Criteria:
Be between the ages of 18 and 45, inclusive
Have a body weight of 45 kg to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
Be healthy based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory test results
If female, be non-pregnant and non-nursing. For either gender, the subject must be either sexually inactive (14 days prior to the first dose of study drug and throughout the study) or practicing at least two methods of birth control from the following list of acceptable forms of contraception:
Has read, understood and signed the IRB-approved informed consent form (ICF)
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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