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AN3365

Phase 1

Gram-negative Bacterial Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 5, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

AN3365 · 1 trial · 1 indication

Phase 1 1
NCT01015014Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial InfectionsGram-negative Bacterial Infection
COMPLETED64 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
Gram-negative Bacterial Infection
NCT0101501464
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Study Endpoints

Primary Endpoints

Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate)
Multiple time points up to 14 days

Secondary Endpoints

Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Multiple time points up to 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AN3365ACTIVE_COMPARATOR -
SalinePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AN3365DRUGLP, 600 mg vial; reconstituted in Normal Saline
PlaceboDRUG0.9% sodium chloride for injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Young healthy males, 18-45 years (inclusive) of age * Healthy as judged by a responsible physician with no clinically significant abnormality * Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during...

Countries:Australia
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Frequently asked questions about AN3365

What is AN3365 used for?

AN3365 is an investigational small molecule being developed for the treatment of Gram-negative bacterial infections. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended to address infections caused by Gram-negative bacteria, which are often resistant to multiple antibiotics.

What does AN3365 target?

AN3365 is a small molecule antibiotic designed to treat Gram-negative bacterial infections. The specific molecular target has not been disclosed in available information. The drug is being studied for its safety, pharmacokinetics, and tolerability in healthy volunteers, with the goal of establishing a foundation for future efficacy studies in infected patients.

Who makes AN3365?

AN3365 is being developed by Pfizer, Inc., a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on this investigational antibiotic for Gram-negative bacterial infections, with the drug currently in Phase 1 development.

What phase is AN3365 in?

AN3365 is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on evaluating the safety, pharmacokinetics, and tolerability of the drug. The drug is investigational and has not received regulatory approval for any indication. Further clinical studies would be required to advance its development.

What clinical trials is AN3365 in?

AN3365 has one completed clinical trial registered as NCT01015014, titled "Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections." This Phase 1 study enrolled 64 healthy male volunteers in Australia and was randomized, double-blind, and placebo-controlled. The trial is now complete.

Is AN3365 the same as any other drug?

AN3365 is the designated name for this investigational compound developed by Pfizer. No alternative names have been associated with this drug in available information. It is a unique small molecule being studied for Gram-negative bacterial infections, distinct from other antibiotics in Pfizer's portfolio.