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LIQ865A bupivacaine formulation

Phase 1

Acute Pain | Small molecule | Pain |Liquidia Corporation|Last Updated: Aug 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

LIQ865A bupivacaine formulation · 1 trial · 1 indication

Phase 1 1
NCT02982889Single Ascending Dose Study of Two Liquidia Bupivacaine FormulationsAcute Pain
COMPLETED29 Analytics
PHASE1COMPLETED
Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations
Acute PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment Emergent Adverse Events (AEs)
30 days

Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study

Secondary Endpoints

Pharmacokinetic - Area under the plasma concentration curve from time zero to Day 5
Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
Pharmacokinetic - Cmax (ng/mL)
Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
Pharmacokinetic - Tmax (h)
Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LIQ865A bupivacaine formulationEXPERIMENTALLiquidia's PRINT bupivacaine free base/PLGA (poly D,L-lactic-co-glycolic acid) suspension for subcutaneous injection at doses ranging from 150mg to 600mg
LIQ865B bupivacaine formulationEXPERIMENTALLiquidia's PRINT bupivacaine free base suspension for subcutaneous injection at doses ranging from 150mg to 600mg
Diluent for LIQ865PLACEBO_COMPARATORNegative control for subcutaneous injection. Each subject will act as his own control, receiving a LIQ865 formulation subcutaneous injection in one calf, and a diluent subcutaneous injection in his other calf
0.5% bupivacaine hydrochorideACTIVE_COMPARATORPositive control arm to be used with one of the LIQ865 cohorts, with each subject acting as his own positive control (i.e., one leg will receive subcutaneous injection of LIQ865A or LIQ865B, and the other leg will receive subcutaneous injection of 0.5% bupivacaine hydrochloride).

Interventions

NameTypeDescription
LIQ865A bupivacaine formulationDRUGsingle subcutaneous injection in medial calf
LIQ865B bupivacaine formulationDRUGsingle subcutaneous injection in medial calf
Diluent for LIQ865DRUGSterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection
0.5% bupivacaine hydrochorideDRUGsingle subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * provide written informed consent prior to enrollment * be a non-smoking male, American Society of Anesthesiologist (ASA) physical class 1 or 2 * have a BMI between 18.5 and 25 kg. inclusive, and a weight of at least 60 kg * be willing and able to participate for the duration o...

Countries:Denmark
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

Frequently asked questions about LIQ865A bupivacaine formulation

What is LIQ865A bupivacaine formulation used for?

LIQ865A bupivacaine formulation is an investigational small molecule being developed for acute pain. It is a bupivacaine formulation intended to manage acute pain, though it is still in early clinical development and not yet approved for any use.

Who makes LIQ865A bupivacaine formulation?

LIQ865A bupivacaine formulation is being developed by Liquidia Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker LQDA. The company is conducting clinical research on this bupivacaine formulation for acute pain.

What phase is LIQ865A bupivacaine formulation in?

LIQ865A bupivacaine formulation is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and tolerability.

What clinical trials is LIQ865A bupivacaine formulation in?

LIQ865A bupivacaine formulation has one completed Phase 1 clinical trial, identified as NCT02982889. This was a single ascending dose study of two Liquidia bupivacaine formulations, conducted in Denmark with 29 healthy male volunteers aged 18 years and older.

Is LIQ865A bupivacaine formulation the same as bupivacaine?

LIQ865A bupivacaine formulation is a specific formulation of bupivacaine, a local anesthetic. It is being developed by Liquidia Corporation for acute pain, and the clinical trial evaluated two Liquidia bupivacaine formulations, including LIQ865A.