NCT00563810

Brief Summary

This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

November 21, 2007

Last Update Submit

November 23, 2007

Conditions

Healthy

Keywords

AdultAged

Outcome Measures

Primary Outcomes (1)

  • To assess safety and tolerability.

Interventions

MYO-029DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 18 to 45 years inclusive on study day 1.
  • Elderly men and women aged 65 to 80 years inclusive on study day 1.
  • Women must be postmenopausal for \> or = 1 year (with estradiol \< 25 pg/mL and an FSH \> 40 mIU/mL).
  • Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram.
  • Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation.
  • Non-smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Stamulumab

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2004

Study Completion

April 1, 2006

Last Updated

November 26, 2007

Record last verified: 2007-11