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ERB-257

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 28, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

ERB-257 · 2 trials · 1 indication

Phase 1 2
NCT00722202Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese MalesHealthy Subjects
COMPLETED48 Analytics
NCT00722501Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257Healthy Subjects
COMPLETED48 Analytics
PHASE1COMPLETED
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
Healthy Subjects
NCT0072220248
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PHASE1COMPLETED
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257
Healthy Subjects
NCT0072250148
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Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of ERB-257 as a single IV dose
4 days
To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects
4 days per group

Secondary Endpoints

To evaluate the pharmacokinetics of ERB-257 as a single IV dose
4 days
To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects
4 days per group
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ERB-257ACTIVE_COMPARATOR7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1, 4, 15, 45, 90, 180, and 300 mg
placeboPLACEBO_COMPARATOR2 placebo subjects per group

Interventions

NameTypeDescription
ERB-257DRUG -
placeboOTHER -
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Eligibility Criteria

Age Range20 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 hi...

Countries:JapanUnited States
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Frequently asked questions about ERB-257

What is ERB-257 used for?

ERB-257 is an investigational small molecule being studied in healthy subjects. It is in Phase 1 clinical development, with completed trials evaluating the safety and pharmacokinetics of ascending single intravenous doses. It is not approved for any indication and remains under investigation.

Who makes ERB-257?

ERB-257 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting early-stage clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is ERB-257 in?

ERB-257 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on the safety and pharmacokinetics of ascending single intravenous doses in healthy subjects. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ERB-257 in?

ERB-257 has two completed Phase 1 trials. NCT00722202 evaluated ascending single IV doses in healthy Japanese males in Japan, enrolling 48 participants. NCT00722501 evaluated ascending single IV doses in healthy subjects in the United States, also enrolling 48 participants. Both were randomized, double-blind, and placebo-controlled.

Is ERB-257 the same as any other drug?

ERB-257 is a distinct investigational small molecule developed by Pfizer. No alternative names for ERB-257 have been reported in the clinical trial records. It is being studied under its own name in Phase 1 trials for healthy subjects.