Study Evaluating Single Doses of ILV-095 in Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: Placebo; Biological: ILV-095

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822835

3226K1-1000

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

ILV-095

Active Comparator group

Description:

6 SC single dose injections

Treatment:

Biological: ILV-095

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo