Healthy Clinical Trial
Official title:
Phase I Study of ASP2408 -Subcutaneous Single-dose, Placebo-controlled Study in Non-elderly Healthy Adult Male Subjects
Verified date | June 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 44 Years |
Eligibility |
Inclusion Criteria: - BMI (at screening): = 17.6 kg/m2, < 26.4 kg/m2 - Healthy, as judged by the investigator or subinvestigator based on the results of medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization (Day -2) to immediately before study drug administration - Subjects who agree to use effective contraception until 90 days after study drug administration Exclusion Criteria: - Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study or is scheduled to receive any investigational drugs - Donated 400 mL of whole blood within 90 days before the study or during the period from the screening, 200 mL of whole blood within 30 days, or blood components within 14 days before the study, or is scheduled to donate 400 mL of whole blood or blood components - Received medication within 7 days before hospitalization (Day -2) or is scheduled to receive medication - Received systemic medications influencing immune functions (e.g., steroids, tacrolimus hydrate, anticancer drugs, and biological products) within 365 days before study drug administration - Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration - Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration - A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG (see Table 3.3-1) at screening or the day before study drug administration (Day -1) - Any deviation of the normal ranges in laboratory tests before study drug administration - Failure to meet any criteria for standard 12-lead ECG for QT assessment at screening - A positive result for tuberculosis test - Concurrent or history of drug allergies, anaphylaxis, or severe allergic reaction - Upper GI disease - Concurrent or previous hepatic disease (e.g., viral hepatitis and drug-induced liver injury) - Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment) - Concurrent or previous respiratory disease (e.g., bronchial asthma and chronic bronchitis; except for a history of childhood asthma) - Previous operation of gut excision - Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis; except for a history of calculus) - Concurrent or previous endocrine disease (e.g., hyperthyroid, abnormality of growth hormone) - Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction) - Concurrent or previous malignant tumor - Concurrent or previous serious infection (e.g., sepsis, pneumonia requiring hospitalization, and pyelonephritis) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG | Up to 90 days after administration | No | |
Secondary | Pharmacokinetics of serum ASP2408 | The pharmacokinetic analysis employed non-compartmental methods using serum concentrations of ASP2408. The following pharmacokinetic parameters were estimated: AUCinf, AUClast, Cmax, CL/F, tmax, t1/2, and Vz/F. | On day-1, day-2, day-3, day-4, day-5, day-6, day-7, day-8, day-9, day-11, day-13, day-15, day-22, day-29 day-43, day-60 and day-90 | No |
Secondary | CD80/CD86 receptor occupancy | On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90 | No | |
Secondary | Total lymphocyte count | On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90 | No | |
Secondary | Peripheral blood lymphocyte subset | On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90 | No |
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