A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects

NCT02125435 | Completed Phase 1

• 1 other identifier: 2408-CL-0101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects; Pharmacokinetics of ASP2408

Keywords

Healthy subjects; ASP2408; pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Pharmacokinetic parameter of ASP2408:Cmax

  Maximum concentration (Cmax)

  Days 1-8, 15, 22, 29, 43, 60, 90

• Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation

  up to 90 days

Secondary Outcomes (4)

• Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot

  Days 1-8, 15, 22, 29, 43, 60, 90

• Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy

  Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90

• Total lymphocyte count

  Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90

• Peripheral lymphocyte subset quantification

  Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90

Study Arms (2)

ASP2408 dose escalation cohort

EXPERIMENTAL

Drug: ASP2408

Placebo dose escalation cohort

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP2408 DRUG

intravenous

ASP2408 dose escalation cohort

Placebo DRUG

intravenous

Placebo dose escalation cohort

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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-SPOT® 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

PAREXEL International

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

ASP2408

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

US (1)