Recent Updates
Recently added Catalysts

BCX4430

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02319772A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430PHASE1 COMPLETED 94Dec 1, 2014Apr 1, 2016Jul 7, 20161 United Kingdom
Unlock Drug Trial Details
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
Unlock Study Endpoints
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 -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria