Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Other: placebo; Drug: ERB-257

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722501

3252K1-1000

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy subjects

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy men and women of non-childbearing potential between the ages of 18 and 50.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg2.
3. 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. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

ERB-257

Active Comparator group

Description:

7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1,4, 15, 45, 90, 180, and 300 mg

Treatment:

Drug: ERB-257

placebo

Placebo Comparator group

Description:

2 placebo subjects per group

Treatment:

Other: placebo