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BCX4430 · 1 trial · 2 indications
Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings
| Arm | Type | Description |
|---|---|---|
| BCX4430 | EXPERIMENTAL | BCX4430 administered as an IM injection |
| Placebo | PLACEBO_COMPARATOR | Matched placebo administered as an IM injection |
| Name | Type | Description |
|---|---|---|
| BCX4430 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs) 2. Body mass index (BMI) of 19-32 kg/m2 3. Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study 4. Sexually active women of child bearing potential and sexually active men must utilize...
BCX4430 is an investigational small molecule being developed for filovirus infections, including Ebola virus infection. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. It is not approved for any indication and remains in clinical development.
BCX4430 targets the viral RNA polymerase, an enzyme essential for viral replication. By acting on this enzyme, the drug is designed to interfere with the virus's ability to copy its genetic material. This mechanism is being explored for the treatment of filovirus infections.
BCX4430 is being developed by BioCryst Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker BCRX. The company is responsible for the research and clinical development of the compound for filovirus infections.
BCX4430 is in Phase 1 clinical development. A single Phase 1 study has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any regulatory agency for filovirus infections.
BCX4430 has been evaluated in one completed Phase 1 trial, NCT02319772, titled "A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430." The trial enrolled 94 healthy adult volunteers in the United Kingdom and was randomized, double-blind, and placebo-controlled.