Approval Probability
TA Base Rate
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NP-015 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
| 2 | PLACEBO_COMPARATOR | Saline (equal volume to 210 U, 420 U, or 840 U TNA dose) |
| Name | Type | Description |
|---|---|---|
| NP-015 | BIOLOGICAL | Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
Inclusion Criteria: * Male or female * Age 18/19 (dependent on local age of majority) - 55 years * Body mass index of 19 - 29 * For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including: * Using hormonal contracept...
NP-015 is an investigational monoclonal antibody being developed for the symptoms of inhalational anthrax. It is intended to address the infectious disease indication of inhalational anthrax. As of the available data, NP-015 is in Phase 1 clinical development and has not been approved by regulatory authorities.
NP-015 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 research on this investigational monoclonal antibody for the treatment of symptoms associated with inhalational anthrax.
NP-015 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial for NP-015 has been completed, and the drug remains in early-stage clinical testing for its intended use in addressing symptoms of inhalational anthrax.
NP-015 has one completed Phase 1 clinical trial registered under NCT00448253, titled 'Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum.' This trial enrolled 92 participants in the United States, including healthy volunteers aged 18 years and older, and was a randomized, double-blind, placebo-controlled study.
NP-015 is not FDA approved. It is an investigational monoclonal antibody currently in Phase 1 clinical development for symptoms of inhalational anthrax. The completed Phase 1 trial assessed safety and pharmacokinetics, but the drug has not yet received marketing authorization from the FDA or any other regulatory body.
NP-015 is a monoclonal antibody, a type of biologic drug designed to target specific components of the immune system or pathogens. However, the specific molecular target of NP-015 has not been disclosed in the available information, so its precise mechanism of action is not detailed here.