Study Evaluating IMA-026 in Healthy Japanese Males

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects

Completed

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Toshima-ku, Tokyo, 171-0014, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men ages 20 to 40 years, inclusive, at screening
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight > 45 kg
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.

Treatment and study plan

IMA-026

Drug

SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV

Primary outcomes

To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Japanese Male Subjects

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 12, 2007
Registry last updated: Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed