Approval Probability
TA Base Rate
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ML Risk
IC84 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| IC84, 75 µg w/ Alum | EXPERIMENTAL | 75 µg w/ Alum (microgram with Alum) |
| IC84, 75 µg w/o Alum | EXPERIMENTAL | 75 µg w/o Alum (microgram without Alum) |
| IC84, 200 µg w/ Alum | EXPERIMENTAL | 200 µg w/ Alum (microgram with Alum) |
| IC84, 200 µg w/o Alum | EXPERIMENTAL | 200 µg w/o Alum (microgram without Alum) |
| Name | Type | Description |
|---|---|---|
| IC84 | BIOLOGICAL | IC84, a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B, which will be administered at two different doses: 75 and 200 µg without or with Al(OH)3, respectively, intramuscular (i.m.) injection, four vaccinations on Day 0, 7, 28 and 56. |
Inclusion Criteria: 1. Healthy adults ≥18 years of age. 2. No clinically relevant pathological findings in any of the investigations at the Screening Visit including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non insulin-...
IC84 is an investigational monoclonal antibody being developed for the prevention or treatment of Clostridium difficile infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
IC84 is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker VALN. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational monoclonal antibody.
IC84 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing clinical evaluation.
IC84 has been studied in one clinical trial, identified as NCT01296386. This was an open-label, controlled Phase 1 study that assessed the safety, immunogenicity, and dose response of IC84 in 82 participants, including healthy volunteers aged 65 years and older.
IC84 is the primary name for this investigational monoclonal antibody. No alternative names have been reported in clinical trial records. It is being developed specifically for Clostridium difficile infection.