Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722202

Enrollment

Registered

2008-07-25

Start date

2008-10-31

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 IV administered ERB-257 as single ascending doses to healthy Japanese male subjects

Interventions

DRUGERB-257

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy Japanese men between the ages of 20 and 50. 2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 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, infection, fever, or diarrhea) within 7 days before study day 1.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of ERB-257 as a single IV dose	4 days

Secondary

Measure	Time frame
To evaluate the pharmacokinetics of ERB-257 as a single IV dose	4 days

Countries

Japan

Outcome results

None listed

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