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LIQ001

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Liquidia Corporation|Trials Updated: Mar 1, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

LIQ001 clinical trials

LIQ001 · 1 trial · 1 indication

Phase 1 1
NCT01224262A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001Influenza
COMPLETED152 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

The rate of Adverse Events attributable to each of the doses of LIQ001 mixed with Fluzone compared to Fluzone alone.
35 days post-vaccination

Secondary Endpoints

HAI response (Geometric Mean Titer) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
HAI response (Percent with HAI titer greater than or equal to 1:40) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
HAI response (Seroconversion rate) of each of the doses of LIQ001 mixed with Fluzone compared to the Fluzone alone response.
21 days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Fluzone + 0.45 mg LIQ001EXPERIMENTALFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (0.45mg)
Fluzone + 1.8 mg LIQ001EXPERIMENTALFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine) Administered with LIQ001 (1.8mg)
FluzoneACTIVE_COMPARATORFluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)

Interventions

NameTypeDescription
Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)BIOLOGICALA single vaccination of Fluzone alone
LIQ001 (0.45mg)BIOLOGICALA single vaccination of 0.45 mg LIQ001
LIQ001 (1.8mg)BIOLOGICALA single vaccination of 1.8 mg LIQ001
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 18 to 49 years (Cohort 1) and age 65 or above (Cohort 2) * For subjects 18 to 49 years of age: in good health as determined by medical history, physical examination, and the clinical judgment of the Principal Investigator (PI) * For subjects 65 years of age and older: in s...

Countries:United States
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Frequently asked questions about LIQ001

What is LIQ001?

LIQ001 is an investigational monoclonal antibody developed by Liquidia Corporation (ticker: LQDA) for influenza. It has been studied as a component of a seasonal influenza vaccine in a Phase 1 clinical trial. LIQ001 is also known as LIQ001 (0.45mg).

What is LIQ001 used for?

LIQ001 is being developed for influenza, a contagious respiratory illness caused by influenza viruses. It has been evaluated in a Phase 1 trial as part of a seasonal influenza vaccine. The goal is to prevent influenza infection.

Who makes LIQ001?

LIQ001 is developed by Liquidia Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol LQDA. Liquidia is responsible for the research and clinical development of LIQ001.

What phase is LIQ001 in?

LIQ001 is in Phase 1 clinical development. It has completed one Phase 1 trial evaluating its safety and tolerability as part of a seasonal influenza vaccine. LIQ001 is investigational and has not been approved by the FDA.

What clinical trials is LIQ001 in?

LIQ001 has been studied in one completed Phase 1 clinical trial, NCT01224262, titled 'A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001.' The trial enrolled 152 healthy adult volunteers in the United States and was randomized, double-blind, and active-controlled.