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BCX4430

Phase 1

Filovirus Infections | Small molecule | Infectious Disease |BioCryst Pharmaceuticals, Inc.|Last Updated: Jul 7, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

BCX4430 · 1 trial · 2 indications

Phase 1 1
NCT02319772A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430Filovirus Infections
COMPLETED94 Analytics
PHASE1COMPLETED
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430
Filovirus InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Part 1: 7 days. Part 2: 14 days

Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings

Secondary Endpoints

Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Part 1: 7 days. Part 2: 14 days
The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430
Part 1: 7 days. Part 2: 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCX4430EXPERIMENTALBCX4430 administered as an IM injection
PlaceboPLACEBO_COMPARATORMatched placebo administered as an IM injection

Interventions

NameTypeDescription
BCX4430DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United Kingdom
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Frequently asked questions about BCX4430

What is BCX4430 used for?

BCX4430 is an investigational small molecule being developed for the treatment of filovirus infections, including Ebola virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BCX4430?

BCX4430 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX.

What phase is BCX4430 in?

BCX4430 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Its Phase 1 trial has been completed.

What clinical trials is BCX4430 in?

BCX4430 has been studied in one completed Phase 1 clinical trial, identified as NCT02319772. This trial evaluated the safety, tolerability, and pharmacokinetics of BCX4430 in 94 healthy volunteers in the United Kingdom.

Is BCX4430 FDA approved?

BCX4430 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for the treatment of filovirus infections.