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

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722501

Enrollment

Registered

2008-07-25

Start date

2008-08-31

Completion date

2008-11-30

Last updated

2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

DRUGERB-257

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects	4 days per group

Secondary

Measure	Time frame
To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects	4 days per group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026