Recent Updates
Recently added Catalysts

Cefazolin

Phase 1

Healthy | Small molecule | Other |Baxter International Inc.|Last Updated: Oct 12, 2022

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05309304Cefazolin PK Study 3g vs 2gPHASE1 COMPLETED 24 — — Feb 14, 2022Aug 30, 2022Oct 12, 20221 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under the curve (AUC)
Day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)

Cefazolin in plasma.

Maximum concentration (Cmax)
Day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)

Cefazolin in plasma

Number of subjects with TEAEs
Day 1 to Day 10

Treatment Emergent Adverse Events (TEAEs)

Number of subjects with Non-serious TEAEs
Day 1 to Day 10
Number of subjects with Serious TEAEs
Day 1 to Day 10
Number of subjects with TEAEs related to study treatment
Day 1 to Day 10
Number of subjects with Serious TEAEs related to study treatment
Day 1 to Day 10
Number of subjects with TEAEs leading to withdrawal
Day 1 to Day 10
Number of subjects with phlebitis at the infusion site
Day 1 to Day 10
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
3 g cefazolinEXPERIMENTALHealthy adult subjects weighing ≥120 kg. (g=grams)
2 g cefazolinACTIVE_COMPARATORHealthy adult subjects weighing \<120 kg. (g=grams)
Interventions
NameTypeDescription
CefazolinDRUGCefazolin Injection - 2 g/100 mL or 3 g/150 mL
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject provides informed consent (approved by an Institutional Review Board \[IRB\]) before any study specific evaluation is performed. * Subject is between the ages of 18 and 55 years (both inclusive). * A female subject is eligible to participate if she is not pregnant, bre...

Countries:United States
Unlock Eligibility Criteria