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Cefazolin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Cefazolin · 1 trial · 1 indication

Phase 1 1
NCT05309304Cefazolin PK Study 3g vs 2gHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Cefazolin PK Study 3g vs 2g
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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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Cefazolin

What is Cefazolin used for?

Cefazolin is a small molecule antibiotic being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics at different doses. The drug is being developed by Baxter International Inc. (BAX).

Who makes Cefazolin?

Cefazolin is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX. The drug is currently in Phase 1 clinical development for use in healthy volunteers.

What phase is Cefazolin in?

Cefazolin is in Phase 1 clinical development. It has one completed Phase 1 trial, which enrolled 24 healthy volunteers in the United States. The drug is investigational and has not been approved for any indication.

What clinical trials is Cefazolin in?

Cefazolin has one completed clinical trial, identified as NCT05309304, titled "Cefazolin PK Study 3g vs 2g." This Phase 1 study enrolled 24 healthy volunteers aged 18 years and older in the United States and evaluated the drug's pharmacokinetics.

Is Cefazolin FDA approved?

Cefazolin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only trial for Cefazolin, NCT05309304, has been completed, but the drug remains under investigation and has not received regulatory approval.