Study of the Safety, Tolerability, PK, and PD of ILV-094... | NCT00434746

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

NCT00434746

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Jul 10, 2009Estimated

Enrollment

56Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

ILV-094

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Feb 9, 2007

First Submission Date that Met QC Criteria

Feb 12, 2007

First Posted Date

Feb 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2009

Last Update Posted Date

Jul 10, 2009Estimated

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ILV-094	Drug	Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide safety, tolerability, PK and immunogenicity profiles		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Ikebukuro	Tokyo	171-0014	Japan

Intervention Browse Module

MeSH Terms

ID	Term
C000629141	fezakinumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided