drugset / Trial / NCT00354263
Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
RandomizedParallel-groupSingle-blindBasic science
Summary
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.
Timeline
- Start
- 2005-04
- Primary completion
- 2005-09
- Completion
- 2006-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMP321 | Protein / enzyme biologic | 3 ug | Subcutaneous |
| Subject | IMP321 | Protein / enzyme biologic | 10 ug | Subcutaneous |
| Subject | IMP321 | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Subject | IMP321 | Protein / enzyme biologic | 100 ug | Subcutaneous |
Indications
No indication recorded.