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Dalbavancin

Phase 1

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 12, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Dalbavancin · 1 trial · 1 indication

Phase 1 1
NCT00678106Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial InfectionsBacterial Infections
COMPLETED10 Analytics
PHASE1COMPLETED
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
Bacterial InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR.
56 days

Secondary Endpoints

Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination.
56 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
DalbavancinDRUGSubjects weighing \> 60 Kg: 1 gram IV single dose Subjects weighing \< 60 Kg: 15 mg/Kg IV
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Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections. Exclusion Criteria: * Patients being treated with vancomycin. * Patients with liver and kidney failure. * Pregnant female subjects.

Countries:United States
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Frequently asked questions about Dalbavancin

What is Dalbavancin used for?

Dalbavancin is an investigational small molecule being developed for the treatment of bacterial infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.

Who makes Dalbavancin?

Dalbavancin is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical research to evaluate the drug's potential in treating bacterial infections.

What phase is Dalbavancin in?

Dalbavancin is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety, tolerability, and pharmacokinetics in patients with bacterial infections.

What clinical trials is Dalbavancin in?

Dalbavancin has one completed clinical trial registered under NCT00678106, titled 'Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections.' This Phase 1 study enrolled 10 participants in the United States and was not randomized or double-blinded.

Is Dalbavancin the same as any other drug?

No alternative names for Dalbavancin have been reported in the available clinical trial information. The drug is identified solely by its generic name, Dalbavancin, in the context of its development by Pfizer for bacterial infections.