Recent Updates
Recently added Catalysts

LIQ001

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01224262A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001PHASE1 COMPLETED 152Sep 1, 2010Dec 1, 2011Mar 1, 20131 United States
Unlock Drug Trial Details
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 — 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