Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

Healthy Clinical Trial

Official title:

Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434746
• Other study ID #: 3199K1-1102
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2007
• Last updated: July 8, 2009
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.

Description:

This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Men aged 20 to 45 years inclusive at screening.

• Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.

• Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.

• Healthy as determined by the investigator on the basis of screening evaluation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ILV-094
Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide safety, tolerability, PK and immunogenicity profiles		1 year	Yes