NCT00517348

Brief Summary

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026 administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

10 months

First QC Date

August 14, 2007

Last Update Submit

June 24, 2009

Conditions

Healthy

Keywords

Adult

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK) analysis

    6 months

Interventions

IMA-026BIOLOGICAL

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* Healthy men and women ages 18 - 50 * Body weight greater than or equal to 50 kilograms * Nonsmoker or fewer than 10 cigarettes per day * No serious infection, i.e., requiring hospitalization or IV antibiotics, or an upper respiratory infection within 1 month before dosing

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78217, United States

Location

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

US(1)