Recent Updates
Recently added Catalysts

KVD824 Prototype 1 modified-release

Phase 1

Hereditary Angioedema | Small molecule | Other |KalVista Pharmaceuticals, Inc.|Last Updated: Nov 12, 2021

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05118958Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) FormulationsPHASE1 COMPLETED 37May 19, 2020Dec 1, 2020Nov 12, 20211 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetics - Tlag
Days 1, 10 and 14

Time prior to the first measurable concentration after single and multiple doses of KVD824

Pharmacokinetics - Tmax
Days 1, 10 and 14

Time of maximum observed concentration after single and multiple doses of KVD824 with and without food

Pharmacokinetics - Cmax
Days 1, 10 and 14

Maximum observed concentration after single and multiple doses of KVD824 with and without food

Pharmacokinetics - Cmax/Dose
Days 1, 10 and 14

Maximum observed concentration divided by dose

Pharmacokinetics - C12
Days 1, 10 and 14

Plasma concentration observed at time 12 h after single and multiple doses

Pharmacokinetics - C24
Days 1, 10 and 14

Plasma concentration observed at time 24 h after single and multiple doses

Pharmacokinetics - Ctrough
Days 2-14

Concentration prior to the morning dose on Days 2-14 and prior to the evening dose on Days 2-13

Pharmacokinetics - Cmin
Days 2-14

Minimum observed concentration during the dosing interval (between dose time and dose time plus tau) after single and multiple doses of KVD824 with and without food

Pharmacokinetics - Cavg
Days 2-14

Average concentration (AUC(0-tau)/tau)

Pharmacokinetics - AUC(0-12)
Days 1, 10 and 14

Area under the curve from time 0 to 12 hours post-dose after single and multiple doses

Pharmacokinetics - AUC(0-12)/Dose
Days 1, 10 and 14

Area under the curve from time 0 to 12 hours post-dose divided by dose

Pharmacokinetics - AUC(0-24)
Days 1, 10 and 14

Area under the curve from time 0 to 24 hours post-dose after single and multiple doses

Pharmacokinetics - AUC(0-24)/Dose
Days 1, 10 and 14

Area under the curve from time 0 to 24 hours post-dose divided by dose

Pharmacokinetics - AUC(0-last)
Days 1, 10 and 14

Area under the curve from time 0 to the time of last measurable concentration after single and multiple doses

Pharmacokinetics - AUC(0-last)/Dose
Days 1, 10 and 14

Area under the curve from time 0 to the time of last measurable concentration divided by dose

Pharmacokinetics - AUC(0-tau)
Days 1, 10 and 14

Area under the curve for the defined interval between doses (tau)

Pharmacokinetics - AUC(0-inf)
Days 1, 10 and 14

Area under the curve from time 0 extrapolated to infinity

Pharmacokinetics - AUC(0-inf)/D
Days 1, 10 and 14

Area under the curve from time 0 extrapolated to infinity divided by dose

Pharmacokinetics - AUCextrap
Days 1, 10 and 14

Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity

Pharmacokinetics - T1/2
Days 1, 10 and 14

Terminal elimination half-life after single and multiple doses of KVD824 with and without food

Pharmacokinetics - Lambda-z
Days 1, 10 and 14

First order rate constant associated with the terminal (log-linear) portion of the curve after single and multiple doses

Pharmacokinetics - CL/F
Days 1, 10 and 14

Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown

Pharmacokinetics - CL/Ftau
Days 1, 10 and 14

Total body clearance calculated using AUC(0-tau) after repeated extravascular administration, where F (fraction of dose bioavailable) is unknown

Pharmacokinetics - Vz/F
Days 1, 10 and 14

Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown

Pharmacokinetics - Vz/Flau
Days 1, 10 and 14

Apparent volume of distribution based on the terminal phase calculated using AUC(0-tau) after extravascular administration where F (fraction of dose bioavailable) is unknown

Pharmacokinetics - Frel Cmax
Days 1, 10 and 14

Relative bioavailability based on Cmax

Pharmacokinetics - Frel AUC(0-12)
Days 1, 10 and 14

Relative bioavailability based on AUC(0-12)

Pharmacokinetics - Frel AUC(0-inf)
Days 1, 10 and 14

Relative bioavailability based on AUC(0-inf)

Pharmacokinetics - AR Cmax
Days 1, 10 and 14

Accumulation ratio based on Cmax repeated dose/Cmax single dose

Pharmacokinetics - Fluctuation
Days 1, 10 and 14

Peak to trough fluctuation (Cmax-Cmin)/Cavg × 100

Secondary Endpoints
Safety - Adverse Events
Change from pre-dose to last visit (up to 14 days)
Safety - Serious Adverse Events
Change from pre-dose to last visit (up to 14 days)
Safety - Laboratory Assessments
Throughout the trial to last visit (up to 14 days)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 - Period 1 - Prototype 1 600 mg (single dose fasted)EXPERIMENTAL600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose
Part 1 - Period 3 - Prototype 2 600 mg (single dose fasted)EXPERIMENTAL600 mg (2 x 300 mg) KVD824 prototype 2 modified-release tablet dosed orally in fasted state as a single dose
Part 1 - Period 4 - Prototype 1 900 mg (single dose fasted)EXPERIMENTAL900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose
Part 1 - Period 5 - Prototype 1 600 mg and Prototype 3 300 mg (single dose fasted)EXPERIMENTAL600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet plus 300 mg (1 x 300 mg) Prototype 3 dosed orally in fasted state as a single dose
Part 1 - Period 6 - Prototype 1 900 mg (single dose fed)EXPERIMENTAL900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fed state as a single dose
Part 3 - KVD824 Prototype 1 600 mg (multiple dose fed)EXPERIMENTAL600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14.
Part 3 - Placebo to KVD824 Prototype 1 600 mg (multiple dose fed)PLACEBO_COMPARATORPlacebo to 600 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14.
Part 3 - KVD824 Prototype 1 900 mg (multiple dose fed)EXPERIMENTAL900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14.
Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fed)PLACEBO_COMPARATORPlacebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14.
Part 3 - KVD824 Prototype 1 900 mg (multiple dose fasted)EXPERIMENTAL900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14.
Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fasted)PLACEBO_COMPARATORPlacebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14.
Part 1 - Period 2 - KVD824 IR Capsule 600 mg (single dose fasted)ACTIVE_COMPARATOR600 mg (2 x 300 mg) KVD824 immediate release Capsule dosed orally in fasted state as a single dose
Interventions
NameTypeDescription
KVD824 Prototype 1 modified-release tabletDRUG300 mg modified-release tablet
KVD824 Prototype 2 modified-release tabletDRUG300 mg modified-release tablet
KVD824 Immediate-Release CapsuleDRUG300 mg immediate-release capsule
Placebo to KVD824 Prototype 1DRUGPlacebo to 300 mg KVD824 Prototype 1 modified-release tablet
KVD824 Prototype 3 modified-release tabletDRUG300 mg modified-release tablet
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males or non-pregnant, non-lactating healthy females. 2. Aged 18 to 55 years, inclusive at the time of signing informed consent. 3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening. 4. Must be willing and able to communicate and participate in the ...

Countries:United Kingdom
Unlock Eligibility Criteria