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BX1000

Phase 2

Neuromuscular Blockade | Small Molecules | Pain |Baudax Bio, Inc.|Trials Updated: Aug 1, 2023

BX1000 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

BX1000 clinical trials

BX1000 · 1 trial · 3 indications

Phase 2 1
NCT05687253Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing SurgeryNeuromuscular Blockade
COMPLETED80 Analytics
PHASE2COMPLETED
Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
Neuromuscular BlockadeUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of Intubation Conditions
Within 2 minutes after administration

Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent

Secondary Endpoints

Assessment of Safety And Tolerability - Adverse Events
Within 30 days after administration
Assessment of Safety And Tolerability - Blood Pressure
Within 30 days after administration
Assessment of Safety And Tolerability - Heart Rate
Within 30 days after administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BX1000 0.15 mg/kgEXPERIMENTALBX1000 0.15 mg/kg IV Bolus
BX1000 0.25 mg/kgEXPERIMENTALBX1000 0.25 mg/kg IV Bolus
BX1000 0.35 mg/kgEXPERIMENTALBX1000 0.35 mg/kg IV Bolus
Rocuronium 0.6 mg/kgACTIVE_COMPARATORRocuronium bromide 0.6 mg/kg IV Bolus

Interventions

NameTypeDescription
BX1000DRUGIV BX1000
Rocuronium BromideDRUGIV Rocuronium
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Providing informed consent * Undergoing elective surgery utilizing IV general anesthesia * Normal airway assessment Exclusion Criteria: * Unstable disease or emergency surgical conditions * Known hypersensitivity to rocuronium, other NMB or study medications * History of ana...

Countries:United States
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