NCT00822835

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

January 13, 2009

Last Update Submit

September 17, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.

    3 weeks per group

Secondary Outcomes (1)

  • Pharmacokinetic parameters

    3 weeks per group

Study Arms (2)

ILV-095

ACTIVE COMPARATOR

6 SC single dose injections

Biological: ILV-095

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

ILV-095BIOLOGICAL
ILV-095
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women of non-childbearing potential ages 18 to 50 years old.
  • Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg.
  • Healthy as determined by the investigator on the basis of screening evaluations.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  • Have a high probability for compliance with and completion of the study.

You may not qualify if:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
  • Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)