Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240

NCT01582399 | Completed Phase 1

• 1 other identifier: 7163-CL-0106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics of ASKP1240; Pharmacodynamics of ASKP1240; Healthy Volunteers

Keywords

Healthy Volunteers; CD40 receptor occupancy; Co-stimulation blockade; CD40 antigen; Anti-CD40; ASKP1240

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Pharmacodynamic profile: CD40 receptor occupancy over time

  Day 15 to Day 90, ± 3 days

• Pharmacodynamic profile: Total lymphocyte count and peripheral lymphocyte subset quantification

  Day 15 to Day 90, ± 3 days

• Pharmacokinetics profile: Cmax, Tmax, t1/2, Vz, and CLtot

  Day 15 to Day 90, ± 3 days

Study Arms (2)

Arm A: ASKP1240 intravenous (IV) infusion

EXPERIMENTAL

Drug: ASKP1240

Arm B: ASKP1240 subcutaneous (SC)

EXPERIMENTAL

Drug: ASKP1240

Interventions

ASKP1240 DRUG

intravenous(IV) infusion and subcutaneous (SC)

Arm A: ASKP1240 intravenous (IV) infusion; Arm B: ASKP1240 subcutaneous (SC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 a) at least two years post-menopausal (defined as at least 2 years without menses) at Screening and a confirmatory follicle stimulating hormone (FSH) level of \>40 U/L at Screening) or b) surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating at Screening and Day -1. c) If child bearing potential, the subject will be required to use adequate contraception consisting of two forms of birth control (one of which must be a barrier method) until the end of the study or for 90 days after final study drug administration, whichever is longer
• The male subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method until the end of study
• Male subject agrees to no sperm donation until the end of the study or for 90 days after the conclusion of study drug administration, whichever is longer

You may not qualify if:

• 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:
• White blood cell count (WBC) is \< 3.5 (109/L) or \> upper limit of normal
• Absolute neutrophil count (ANC) is \< 1.5 (109/L) 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 \> 2x times upper limit of normal

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (1)

Parexel

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

bleselumab

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

US (1)