Recent Updates
Recently added Catalysts

LIQ001

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about LIQ001

What is LIQ001 used for?

LIQ001 is an investigational monoclonal antibody being studied for use in influenza. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated for its safety and tolerability in a clinical trial setting.

Who is developing LIQ001?

LIQ001 is being developed by Liquidia Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol LQDA. The company is conducting clinical research to evaluate the drug's potential as a treatment for influenza.

What phase is LIQ001 in?

LIQ001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for influenza.

What clinical trials is LIQ001 in?

LIQ001 has been studied in a Phase 1 clinical trial registered as NCT01224262. This completed trial evaluated the safety and tolerability of a seasonal influenza vaccine containing LIQ001 in 152 healthy adult volunteers in the United States.

Is LIQ001 the same as a seasonal influenza vaccine?

LIQ001 is a monoclonal antibody that was evaluated in a clinical trial as part of a seasonal influenza vaccine. The trial, NCT01224262, assessed the safety and tolerability of the vaccine containing LIQ001, but LIQ001 itself is the investigational drug being studied.