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hepatitis B antigen plus IMP321 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | IMP321 |
| B | PLACEBO_COMPARATOR | Saline |
| C | ACTIVE_COMPARATOR | Engerix B |
| Name | Type | Description |
|---|---|---|
| hepatitis B antigen (without alum) plus IMP321 | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 |
| hepatitis B antigen alone (without alum) | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline |
| Engerix B | BIOLOGICAL | 20 µg hepatitis B antigen absorbed on alum |
Inclusion Criteria: * able to give a written informed consent ; * healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years; * with body mass index (weight/height²) in the range 18 to 30 kg/m²; * registered with the French Social Security in...
Hepatitis B antigen plus IMP321 is an investigational combination being studied in healthy volunteers. It combines a hepatitis B antigen with IMP321, a monoclonal antibody, and is being evaluated in a Phase 1 clinical trial. The study is not designed for a specific disease condition, as it enrolls healthy participants.
Hepatitis B antigen plus IMP321 is being developed by Immutep Limited, a biopharmaceutical company traded on the NASDAQ under the ticker IMMP. The company is conducting a Phase 1 clinical trial of this combination in healthy volunteers.
Hepatitis B antigen plus IMP321 is in Phase 1 clinical development. It is an investigational combination and has not been approved by regulatory authorities. The Phase 1 study is completed, having enrolled 48 healthy participants in France.
Hepatitis B antigen plus IMP321 is associated with one completed clinical trial, NCT00354861. This was a randomized, placebo-controlled Phase 1 study of a hepatitis B antigen combined with IMP321 in healthy volunteers. The trial enrolled 48 participants aged 18 years and older in France.
Hepatitis B antigen plus IMP321 is a combination product that includes IMP321, a monoclonal antibody, along with a hepatitis B antigen. It is distinct from IMP321 alone, as the combination is specifically being studied for its effects when the antigen and antibody are given together.