Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics of ASKP1240, Healthy Volunteers

In brief

The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.

Key facts

Study ID

NCT01565681

Run by

Astellas Pharma Global Development, Inc.

People needed

109

Starts

2009-01-01

Expected to finish

2009-12-01

Last updated by the study team

2012-12-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
• The female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L)
• Male subject agrees to no sperm donation until end of study or 90 days post dose, whichever is longer
• The subject is highly likely to comply with the protocol and complete the study
• The subject has a negative urine screen for drugs of abuse, and negative blood or breathalyzer alcohol screen at Screening and clinic admission on Day 1

You may not qualify if…

• The subject has a history of severe allergic or anaphylactic reactions
• The subject has 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 prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
• The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
• The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or pulse rate higher than 100 beats per min (bpm), either at screening or clinic check in (blood pressure measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
• The subject is known positive for human immunodeficiency virus (HIV) antibody
• The subject has a positive test for hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg)
• The subject has at screening or clinic check in that:
• white blood cell count (WBC) is < 3.5 or > upper limit of normal
• absolute neutrophil count (ANC) is <1.5 or > upper limit of normal
• platelet count (PLT) is outside the normal limit
• serum creatinine, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) are > upper limit of normal
• creatine phosphokinase (CPK) is > two times upper limit of normal
• international normalized ratio (INR) is > upper limit of normal
• OR remaining laboratory tests are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per protocol laboratory tests
• The subject has received a vaccine within 60 days prior to study drug administration
• The subject has received any systemic immunosuppressant agent within 6 months prior to study drug administration.
• The subject has received any antibody or biologic product within 6 months prior to study drug administration
• The subject has received any systemic steroid within 2 months prior to study drug administration
• The subject has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines (CAM) and excluding over-the-counter (OTC) allergy medications, nasal steroids, nasal inhalers, oral contraceptives, stable hormone replacement therapy (HRT; per Investigator judgment and dose change not expected during study), and intermittent acetaminophen, within 14 days prior to study drug administration
• The subject has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
• The subject is participating in another clinical trial or has participated in another dose group of the current trial
• The subject has donated or has had significant blood loss or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to dosing
• The subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to Screening
• The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis, pulmonary embolism and varices
• The subject has a positive test for tuberculosis

Where it is running

• Parexel — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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