Study Evaluating Single Doses of ILV-095 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822835
• Other study ID #: 3226K1-1000
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2009
• Last updated: September 17, 2009
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy men and women of non-childbearing potential ages 18 to 50 years old.

2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg.

3. Healthy as determined by the investigator on the basis of screening evaluations.

4. 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.

5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.

2. 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.

3. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.

Study Design

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• ILV-095

• 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

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic parameters		3 weeks per group	No