Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
MedImmune LLC |
---|---|
Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00116168 |
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Biological: MEDI-528 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528 |
Estimated Enrollment: | 24 |
Study Start Date: | June 2005 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
MEDI-528
|
Biological: MEDI-528
0.3 mg/kg SC at Study Day 0
|
2: Active Comparator
MEDI-528
|
Biological: MEDI-528
1.0 mg/kg SC at Study Day 0
|
3: Active Comparator
MEDI-528
|
Biological: MEDI-528
3.0 mg/kg SC at Study Day 0
|
4: Active Comparator
MEDI-528
|
Biological: MEDI-528
9.0 mg/kg SC at Study Day 0
|
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.
Ages Eligible for Study: | 19 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Louisiana | |
MDS Pharma Services | |
New Orleans, Louisiana, United States, 70119 | |
United States, Nebraska | |
MDS Pharma Services | |
Lincoln, Nebraska, United States, 68502 |
Study Director: | Barbara White, M.D. | MedImmune LLC |
Study ID Numbers: | MI-CP109 |
Study First Received: | June 27, 2005 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00116168 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy |