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AVP-21D9 · 1 trial · 1 indication
Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable.
| Arm | Type | Description |
|---|---|---|
| AVP-21D9 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AVP-21D9 | DRUG | intravenously, single dose |
| Placebo | DRUG | Placebo comparator |
Key Inclusion Criteria: * Healthy volunteers, between 18 and 45 years of age * Normal laboratory (blood test) results Key Exclusion Criteria: * Prior immunization with anthrax vaccine
AVP-21D9 is an investigational small molecule being developed for anthrax, a serious infectious disease. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied for its safety and pharmacokinetics in healthy volunteers.
AVP-21D9 is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
AVP-21D9 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of anthrax.
AVP-21D9 has one completed Phase 1 clinical trial, identified as NCT01202695. This study, titled 'Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)', enrolled 50 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, involving healthy volunteers aged 18 years and older.
Although AVP-21D9 is classified as a small molecule, the completed Phase 1 clinical trial NCT01202695 is titled 'Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)'. The trial description refers to the drug as a human monoclonal antibody, which may indicate its mechanism of action.