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| Name | Class |
|---|---|
| Kyowa Kirin Co., Ltd. | INDUSTRY |
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The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how the drug behaves inside the body and how it is eliminated from the body by looking at the pharmacokinetics of ASP1240.
In addition, the study will determine the effects of ASKP1240 on the body by looking at its pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as SC injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: ASKP1240 intravenous (IV) infusion | Experimental |
| |
| Arm B: ASKP1240 subcutaneous (SC) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKP1240 | Drug | intravenous(IV) infusion and subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: AUClast, AUCinf, and F | Area under the serum concentration- time curve from time 0 up to the last quantifiable concentration (AUClast), Area under the serum concentration- time curve from time 0 extrapolated to infinity (AUCinf), and Absolute bioavailability (F) | Day 15 to Day 90, ± 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic profile: CD40 receptor occupancy over time | Cell surface antigen, target of ASKP1240 (CD40), as measured on CD20+ B lymphocytes | Day 15 to Day 90, ± 3 days |
| Pharmacodynamic profile: Total lymphocyte count and peripheral lymphocyte subset quantification |
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Inclusion Criteria:
Exclusion Criteria:
The subject has a history or evidence of any clinically significant (as determined by the Investigator) cardiovascular, endocrine, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
The subject has a history of severe allergic or anaphylactic reactions
The subject has a history of consuming more than 14 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week on average within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening or the subject tests positive at Screening or Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
The subject has/had a symptomatic, viral, bacterial or fungal (non-cutaneous) infection within 1 week prior to clinic check in on Day -1
The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis or pulmonary embolism
The subject has used any tobacco-containing products, nicotine or nicotine-containing products in the past 6 months prior to Screening
The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean heart rate > 100 beats per minute (bpm), either at Screening or Day -1 (measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
The subject is known to be positive for human immunodeficiency virus (HIV) antibody
The subject has a positive test for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody at Screening
The subject has the following at Screening or Day -1:
The subject has received any vaccine within 60 days prior to Day -1
The subject has received any systemic immunosuppressant agent (e.g., methotrexate) within 6 months prior to Day -1
The subject has received any systemic steroid within 2 months prior to Day -1
The subject has received any antibody or therapeutic biologic product within 6 months prior to Day -1
The subject has used prescription or non-prescription medications (excluding acetaminophen [up to 2 g/day maximum], stable hormone replacement therapy [HRT], and/or nasal steroids/steroid inhaler), or complementary and alternative medicines (CAM) within 14 days or 5 half lives (whichever is longer) prior to Day -1
The subject has a positive TB skin test, Quantiferon Gold test or T-SPOT test® at Screening
The subject has participated in a previous ASKP1240 study
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel | Baltimore | Maryland | 21225 | United States |
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Total lymphocyte count = product of the white blood count (WBC) and percent lymphocytes [from differential] |
| Day 15 to Day 90, ± 3 days |
| Pharmacokinetics profile: Cmax, Tmax, t1/2, Vz, and CLtot | Maximum concentration (Cmax),Time to attain Cmax (Tmax), Apparent terminal elimination of half-life (t1/2), Apparent volume of distribution ( Vz), and Total body clearance (CLtot) | Day 15 to Day 90, ± 3 days |
| ID | Term |
|---|---|
| C586087 | bleselumab |
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