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galidesivir

Phase 1

Marburg Virus Disease | Small molecule | Other |BioCryst Pharmaceuticals, Inc.|Last Updated: Jul 23, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03800173A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430PHASE1 COMPLETED 32 — — Dec 10, 2018Apr 30, 2019Jul 23, 20211 United States
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Study Endpoints
Primary Endpoints
Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.

Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).

Secondary Endpoints
Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)
Plasma PK parameters are based on sampling over a 21 day period
Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)
Plasma PK parameters are based on sampling over a 21 day period
Galidesivir Renal Clearance
Urine PK parameters are based on sampling over a 96 hour period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GalidesivirEXPERIMENTALGalidesivir IV infusion
placeboPLACEBO_COMPARATORPlacebo IV infusion
Interventions
NameTypeDescription
galidesivirDRUGgalidesivir IV infusion
placeboDRUGplacebo IV infusion
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * written informed consent * males and non-pregnant, non-lactating females * BMI 19.0-32.0 * willing to abide by contraceptive requirements * normal vitals * willing to abide by study procedures and restrictions Exclusion Criteria: * clinically significant medical conditio...

Countries:United States
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