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LBR-101

Phase 1

Bioavailability and Pharmacokinetics | Monoclonal antibody | Other |Teva Pharmaceutical Industries Limited|Last Updated: Mar 4, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

LBR-101 · 1 trial · 1 indication

Phase 1 1
NCT01991509Safety and Bioavailability of IV and SC LBR-101Bioavailability and Pharmacokinetics
COMPLETED36 Analytics
PHASE1COMPLETED
Safety and Bioavailability of IV and SC LBR-101
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Study Endpoints

Primary Endpoints

Relative bioavailability of IV versus SC Administration of LBR-101
30 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
LBR-101 IV Dose 1EXPERIMENTALLBR-101 Dose 1 Administered Intravenously
LBR-101 SC Dose 1EXPERIMENTALLBR-101 Dose 1 Administered Subcutaneously
Placebo IVPLACEBO_COMPARATORPlacebo Administered Intravenously
Placebo SCPLACEBO_COMPARATORPlacebo Administered Subcutaneously
LBR-101 Dose 2 IVEXPERIMENTALLBR-101 Dose 2 Administered Intravenously
LBR-101 Dose 2 SCEXPERIMENTALLBR-101 Dose 2 Administered Subcutaneously

Interventions

NameTypeDescription
LBR-101 IVBIOLOGICALLBR-101 Administered Intravenously
LBR-101 SCBIOLOGICALLBR-101 Administered Subcutaneously
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule Exclusion Criteria: * Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant...

Countries:United States
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Frequently asked questions about LBR-101

What is LBR-101 used for?

LBR-101 is a monoclonal antibody being studied for bioavailability and pharmacokinetics. It is in Phase 1 clinical development, with a completed trial evaluating its safety and bioavailability when given intravenously and subcutaneously. The study involved healthy volunteers in the United States.

What does LBR-101 target?

LBR-101 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its bioavailability and pharmacokinetic properties in a Phase 1 clinical trial.

Who is developing LBR-101?

LBR-101 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The drug is currently in Phase 1 clinical development.

What phase is LBR-101 in?

LBR-101 is in Phase 1 clinical development. One Phase 1 trial has been completed, which studied the safety and bioavailability of the drug when administered intravenously and subcutaneously in healthy volunteers.

What clinical trials is LBR-101 in?

LBR-101 has one completed clinical trial, NCT01991509, titled 'Safety and Bioavailability of IV and SC LBR-101'. This Phase 1 study enrolled 36 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is LBR-101 the same as any other drug?

LBR-101 is a distinct investigational monoclonal antibody. No alternative names for LBR-101 have been reported. It is being studied for its bioavailability and pharmacokinetics in early-stage clinical trials.