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Dalbavancin

Phase 1

Bacterial Infections. | Small molecule | Infectious Disease |cbdMD, Inc.|Last Updated: Jun 23, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Dalbavancin · 1 trial · 1 indication

Phase 1 1
NCT01946568A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.Bacterial Infections.
COMPLETED36 Analytics
PHASE1COMPLETED
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
Bacterial Infections.Unlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.
At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

Secondary Endpoints

To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.
one year
To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).
one year
To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.
one year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Single dose DalbavancinEXPERIMENTAL -

Interventions

NameTypeDescription
DalbavancinDRUGIntravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients \<5 years of age.
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Eligibility Criteria

Age Range3 Months to 11 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Hospitalized patients who will be receiving at least 24 hours of appropriate non-investigational intravenous anti-infective treatment for known or suspected bacterial infections with the exception of urinary tract infections. * Written parental informed consent. * Able to comp...

Countries:United StatesEstonia
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Frequently asked questions about Dalbavancin

What is Dalbavancin used for?

Dalbavancin is used for the treatment of bacterial infections. It is currently in Phase 1 clinical development as an investigational small molecule therapy for this indication.

Who is developing Dalbavancin?

Dalbavancin is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD.

What phase is Dalbavancin in?

Dalbavancin is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is Dalbavancin in?

Dalbavancin has one completed Phase 1 clinical trial, identified as NCT01946568. This trial investigated the pharmacokinetics and safety of a single dose of Dalbavancin in hospitalized children aged 3 months to 11 years.

Is Dalbavancin the same as any other drug?

Dalbavancin is also known by the name Dalbavancin, and no alternative names have been reported for this drug in clinical development.