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VAL-506440 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| VAL-506440 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VAL-506440 | BIOLOGICAL | Escalating dose levels |
| Placebo | OTHER | - |
Inclusion * Agrees to comply with the study procedures and provides written informed consent * 18 to 64 years of age * Body mass index between 18 and 30 kg/m2 * Negative urine pregnancy test at the Screening visit and the day of each vaccination. * Female subjects must either be of non-childbearing...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
VAL-506440 is an investigational drug being developed for influenza, a viral infection of the respiratory tract. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and immunogenicity in healthy adult subjects.
VAL-506440 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange. Moderna is conducting clinical trials to evaluate the drug's potential as a preventive or therapeutic intervention for influenza.
VAL-506440 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 201 healthy adult subjects in Germany. The drug remains investigational and has not received FDA approval or any other regulatory approval for marketing.
VAL-506440 has one completed clinical trial registered under NCT03076385, titled 'Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects.' This Phase 1 study enrolled 201 participants in Germany and was a randomized, double-blind, placebo-controlled trial.
No, VAL-506440 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed safety, tolerability, and immunogenicity in healthy adults, but the drug has not yet received approval from the FDA or any other regulatory agency.
Yes, VAL-506440 is classified as a monoclonal antibody modality. It is being developed by Moderna, Inc. for the prevention or treatment of influenza. The drug is currently in Phase 1 clinical trials, and its mechanism of action has not been fully disclosed in available information.