A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections

NCT02150070 | Completed Phase 1

• 1 other identifier: 2408-CL-0102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.

Conditions

Pharmacokinetics of ASP2408; Healthy Subjects

Keywords

Healthy subjects; ASP2408; Rheumatoid arthritis; Safety and Tolerability; 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 1-9, 11, 13, 15, 22, 29, 43, 60, and 90

• Pharmacokinetic parameter of ASP2408: AUCinf

  Area under the concentration - Time curve from time 0 extrapolated to infinity (AUCinf)

  Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90

• Pharmacokinetic parameter of ASP2408: Cmax

  Maximum concentration (Cmax)

  Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90

• Safety assessed by adverse events (AEs), laboratory tests, immunoglobulin quantification (class), 12-lead electrocardiograms, vital signs and anti-ASP2408 antibody formation

  Up to day 90

Secondary Outcomes (2)

• Composite of pharmacokinetics of ASP2408: tmax, t 1/2, Vz/F, CL/F and F (%)

  Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90

• Pharmacodynamic Profile: CD80 and CD86 receptor occupancy, peripheral lymphocyte subset quantification (leukocyte phenotypes) and total lymphocyte count

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

Study Arms (6)

Intravenous ASP2408

EXPERIMENTAL

Drug: ASP2408

Subcutaneous ASP2408 low dose

EXPERIMENTAL

Drug: ASP2408

Subcutaneous ASP2408 middle dose

EXPERIMENTAL

Drug: ASP2408

Subcutaneous ASP2408 high dose

EXPERIMENTAL

Drug: ASP2408

Intravenous Placebo

PLACEBO COMPARATOR

Drug: Placebo

Subcutaneous Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP2408 DRUG

Intravenous (IV) infusion and subcutaneous (SC) injection

Intravenous ASP2408; Subcutaneous ASP2408 high dose; Subcutaneous ASP2408 low dose; Subcutaneous ASP2408 middle dose

Placebo DRUG

Intravenous (IV) infusion and Subcutaneous (SC) injection

Intravenous Placebo; Subcutaneous Placebo

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, a maximum of 92.5 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
• The subject's 12-lead electrocardiogram (ECG) results are normal
• The female subject must be at least two years postmenopausal OR surgically sterile and not pregnant or lactating
• The male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer

You may not qualify if:

• The 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
• The subject has a history of severe allergic or anaphylactic reactions
• The subject is a female of childbearing potential
• The 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 the past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
• The subject has a positive test for alcohol or drugs of abuse
• 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 past history of opportunistic infection
• 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 pulse rate higher than 100 beats per minute (bpm)
• The subject is known positive for human immunodeficiency virus (HIV) antibody
• The subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test
• The 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 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values are greater than 1.5 times the upper limit of normal
• Subject's laboratory test results are outside the normal limits and considered to be clinically significant
• The subject received any vaccine within 60 days prior to study drug administration
• The subject received any systemic immunosuppressant agent within 2 months 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

Conditions

Arthritis, Rheumatoid

Interventions

ASP2408

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Senior 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: May 27, 2014
• First Posted: May 29, 2014
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (1)