CAZ104

Recently added Catalysts

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 1, 2017

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker

Total Trials2

Total Enrollment88

FDA Designations

No designations recorded

Clinical Trials (2)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT01430910	A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately	PHASE1	COMPLETED	43	—	—	Sep 1, 2011	Oct 1, 2012	Sep 1, 2017	1	United Kingdom
NCT01395420	Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma	PHASE1	COMPLETED	45	—	—	Aug 1, 2011	Jul 1, 2012	Sep 1, 2017	1	United Kingdom

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Study Endpoints

Primary Endpoints

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including maximum plasma concentration (Cmax)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including time of Cmax (tmax)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including minimum plasma concentration (Cmin)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including time of Cmin (tmin)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including last quantifiable plasma concentration (Clast)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including time of Clast (tlast)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including average plasma concentration during a dosing interval (Cavg)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including fluctuation index

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including area under the curve of plasma drug concentration (AUC) - time curve from zero to the time of the last quantifiable concentration

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including AUC, Day 1 only

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including AUC during the dosing interval [AUC(0-τ)]

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including terminal half-life (t1/2)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including systemic plasma clearance (CL)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including volume of distribution at steady state (Vss)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including volume of distribution at the terminal phase (Vz)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including accumulation ratio for Cmax and AUC(0-τ)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Plasma pharmacokinetic variables will be measured including linearity index

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Urine pharmacokinetic variables will be measured including amount of drug excreted unchanged into urine from zero to time t [Ae(0-t)]

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Urine pharmacokinetic variables will be measured including fraction of dose excreted unchanged into urine (fe; % dose)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Avibactam. Urine pharmacokinetic variables will be measured including renal clearance (CLR)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Cmax

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including tmax

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Cmin

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including tmin

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Clast

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including tlast

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Cavg

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including fluctuation index

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including AUC(0-t)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including AUC, Day 1 only

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including AUC(0-τ)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including t1/2

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including CL

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Vss

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including Vz

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including accumulation ratio for Cmax and AUC(0-τ)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Plasma pharmacokinetic variables will be measured including linearity index

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Urine pharmacokinetic variables will be measured including Ae(0-t)

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Urine pharmacokinetic variables will be measured including fe; % dose

Up to 24 hours post last dose

Part A: Single- and multiple-dose pharmacokinetics of Ceftazidime. Urine pharmacokinetic variables will be measured including CLR

Up to 24 hours post last dose

Part B: Pharmacokinetics of co-administering Avibactam plus Ceftazidime (CAZ104) compared to administration of the individual components. Plasma pharmacokinetic variables will be measured including Cmax

Up to 24 hours post last dose

Part B: Pharmacokinetics of co-administering Avibactam plus Ceftazidime (CAZ104) compared to administration of the individual components. Urine pharmacokinetic variables will be measured including Ae(0-t)

Up to 24 hours post last dose

To measure and compare the concentration of Avibactam and Ceftazidime in ELF and plasma

at several timepoints from pre-dose up to 5 days post dose (Part 2)

To measure and compare the concentration of Avibactam and Ceftazidime in ELF and plasma by assessment of maximum concentration (Cmax), time to Cmax (tmax), area under the concentration time curve during a dosing interval t (AUCτ), terminal half life (t½λz) in plasma and ELF, plasma clearance (CL), volume of distribution at steady state (Vss) and at the terminal phase (Vz) in plasma, ratio of Cmax in ELF over Cmax in plasma and ratio of AUCτ in ELF over AUCτ in plasma.

Secondary Endpoints

To assess safety and tolerability of Avibactam by assessment of Adverse events

Up to 24 hours post last dose

To assess safety and tolerability of Avibactam by clinical laboratory assessments

Up to 24 hours post last dose

To assess safety and tolerability of Avibactam by assessment of vital signs

Up to 24 hours post last dose

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
1	EXPERIMENTAL	CAZ104 (2000mg Ceftazidime/500mg Avibactam)
2	ACTIVE_COMPARATOR	500mg Avibactam
3	ACTIVE_COMPARATOR	2000mg Ceftazidime

Interventions

Name	Type	Description
CAZ104	DRUG	IV infusion
Avibactam	DRUG	IV infusion
Ceftazidime	DRUG	IV infusion

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Eligibility Criteria

Age Range18 Years — 50 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and female subjects aged 18 to 50 years with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. Fem...

Countries:United Kingdom

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Recent Updates

Recently added Catalysts

CAZ104

Success Probability

Market & Valuation

Trial Design

FDA Designations

Clinical Trials (2)

Study Endpoints

Primary Endpoints

Secondary Endpoints

Study Design & Arms

Treatment Arms

Interventions

Eligibility Criteria