Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Immutep S.A. SGS Aster-Cephac (CRO) |
---|---|
Information provided by: | Immutep S.A. |
ClinicalTrials.gov Identifier: | NCT00354263 |
This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Biological: IMP321 Biological: saline |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | IMP321 Phase I Study of Four Increasing Doses (3, 10, 30 and 100 µg) of a New Immunostimulatory Factor (IMP321) Given Alone or as an Adjuvant to a Reference Flu Antigen in Healthy Young Male Volunteers |
Enrollment: | 60 |
Study Start Date: | April 2005 |
Study Completion Date: | February 2006 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator
PBS injected alone in step 1 or mixed with Aggripal in step 2
|
Biological: saline
saline injected alone in step 1 or mixed with Aggripal in step 2
|
B: Experimental |
Biological: IMP321
This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Immutep S.A. ( F. Triebel, Chief Medical Officer ) |
Study ID Numbers: | P001, Aster-P020255 |
Study First Received: | July 19, 2006 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00354263 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Healthy male volunteers IMP321 Adjuvant Monotherapy Pharmacokinetics/Pharmacodynamics |
Influenza, Human Healthy |