Healthy Subjects Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
Verified date | April 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
Status | Completed |
Enrollment | 65 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. - Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator. - Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating. - Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer. - Subject is highly likely to comply with the protocol and complete the study. Exclusion Criteria: - Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer. - Subject has a history of severe allergic or anaphylactic reactions. - Subject is a female of child-bearing potential. - Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). - Subject has a positive test for alcohol or drugs of abuse. - Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in. - Subject has a past history of opportunistic infection. - Subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean pulse rate higher than 100 beats per min (bpm). - Subject is known positive for human immunodeficiency virus (HIV) antibody. - Subject has a positive TB skin test or Quantiferon Gold test or T-SPOTĀ® test at Screening. - Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody. - Subject's laboratory test results: - alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), are greater than 1.5 times the upper limit of normal - are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests. - Subject received any vaccine within 60 days prior to study drug administration. - Subject received any systemic immunosuppressant agent within 2 months prior to study drug administration. - Subject has previously received any antibody or therapeutic biologic product prior to study drug administration. - Subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration. - Subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration. - Subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration. - Subject is participating in another clinical trial or has participated in another dose group of the current trial. - Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1. - Subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | PAREXEL International | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Global Development, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameter of ASP2408:AUClast | Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast) | Days 1-8, 15, 22, 29, 43, 60, 90 | No |
Primary | Pharmacokinetic parameter of ASP2408: AUCinf | Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf) | Days 1 -8, 15, 22, 29, 43, 60, 90 | No |
Primary | Pharmacokinetic parameter of ASP2408:Cmax | Maximum concentration (Cmax) | Days 1-8, 15, 22, 29, 43, 60, 90 | No |
Primary | Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation | up to 90 days | No | |
Secondary | Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot | Time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), Terminal phase volume (Vz), Total Body Clearance (CLtot) | Days 1-8, 15, 22, 29, 43, 60, 90 | No |
Secondary | Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy | Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90 | No | |
Secondary | Total lymphocyte count | Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90 | No | |
Secondary | Peripheral lymphocyte subset quantification | Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90 | No |
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