A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male Subjects

NCT02140125 | Completed Phase 1

• 1 other identifier: 2408-CL-9101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.

Conditions

Healthy; Pharmacokinetics of ASP2408

Keywords

ASP2408

Outcome Measures

Primary Outcomes (1)

• Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG

  Up to 90 days after administration

Secondary Outcomes (4)

• Pharmacokinetics of serum ASP2408

  On day-1, day-2, day-3, day-4, day-5, day-6, day-7, day-8, day-9, day-11, day-13, day-15, day-22, day-29 day-43, day-60 and day-90

• CD80/CD86 receptor occupancy

  On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90

• Total lymphocyte count

  On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90

• Peripheral blood lymphocyte subset

  On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90

Study Arms (4)

ASP2408 low dose group

EXPERIMENTAL

Drug: ASP2408

ASP2408 middle dose group

EXPERIMENTAL

Drug: ASP2408

ASP2408 high dose group

EXPERIMENTAL

Drug: ASP2408

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP2408 DRUG

subcutaneous administration

ASP2408 high dose group; ASP2408 low dose group; ASP2408 middle dose group

Placebo DRUG

subcutaneous administration

Placebo group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI (at screening): ≥ 17.6 kg/m2, \< 26.4 kg/m2
• Healthy, as judged by the investigator or subinvestigator based on the results of medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization (Day -2) to immediately before study drug administration
• Subjects who agree to use effective contraception until 90 days after study drug administration

You may not qualify if:

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study or is scheduled to receive any investigational drugs
• Donated 400 mL of whole blood within 90 days before the study or during the period from the screening, 200 mL of whole blood within 30 days, or blood components within 14 days before the study, or is scheduled to donate 400 mL of whole blood or blood components
• Received medication within 7 days before hospitalization (Day -2) or is scheduled to receive medication
• Received systemic medications influencing immune functions (e.g., steroids, tacrolimus hydrate, anticancer drugs, and biological products) within 365 days before study drug administration
• Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration
• Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration
• A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG (see Table 3.3-1) at screening or the day before study drug administration (Day -1)
• Any deviation of the normal ranges in laboratory tests before study drug administration
• Failure to meet any criteria for standard 12-lead ECG for QT assessment at screening
• A positive result for tuberculosis test
• Concurrent or history of drug allergies, anaphylaxis, or severe allergic reaction
• Upper GI disease
• Concurrent or previous hepatic disease (e.g., viral hepatitis and drug-induced liver injury)
• Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
• Concurrent or previous respiratory disease (e.g., bronchial asthma and chronic bronchitis; except for a history of childhood asthma)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Interventions

ASP2408

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

JP (1)