drugset / Trial / NCT00354861
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
RandomizedParallel-groupSingle-blindBasic science
Summary
This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized study.
Timeline
- Start
- 2005-05
- Primary completion
- 2005-11
- Completion
- 2006-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Engerix-B | Vaccine | 20 ug | Intramuscular |
| 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 |
| Background | Hepatitis B vaccine | Vaccine | 10 ug | Subcutaneous |
Indications
No indication recorded.