Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KVD824 Prototype 1 modified-release tablet
KVD824 Prototype 1 modified-release · 1 trial · 1 indication
Time prior to the first measurable concentration after single and multiple doses of KVD824
Time of maximum observed concentration after single and multiple doses of KVD824 with and without food
Maximum observed concentration after single and multiple doses of KVD824 with and without food
Maximum observed concentration divided by dose
Plasma concentration observed at time 12 h after single and multiple doses
Plasma concentration observed at time 24 h after single and multiple doses
Concentration prior to the morning dose on Days 2-14 and prior to the evening dose on Days 2-13
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
Average concentration (AUC(0-tau)/tau)
Area under the curve from time 0 to 12 hours post-dose after single and multiple doses
Area under the curve from time 0 to 12 hours post-dose divided by dose
Area under the curve from time 0 to 24 hours post-dose after single and multiple doses
Area under the curve from time 0 to 24 hours post-dose divided by dose
Area under the curve from time 0 to the time of last measurable concentration after single and multiple doses
Area under the curve from time 0 to the time of last measurable concentration divided by dose
Area under the curve for the defined interval between doses (tau)
Area under the curve from time 0 extrapolated to infinity
Area under the curve from time 0 extrapolated to infinity divided by dose
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
Terminal elimination half-life after single and multiple doses of KVD824 with and without food
First order rate constant associated with the terminal (log-linear) portion of the curve after single and multiple doses
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown
Total body clearance calculated using AUC(0-tau) after repeated extravascular administration, where F (fraction of dose bioavailable) is unknown
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
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
Relative bioavailability based on Cmax
Relative bioavailability based on AUC(0-12)
Relative bioavailability based on AUC(0-inf)
Accumulation ratio based on Cmax repeated dose/Cmax single dose
Peak to trough fluctuation (Cmax-Cmin)/Cavg × 100
| Arm | Type | Description |
|---|---|---|
| Part 1 - Period 1 - Prototype 1 600 mg (single dose fasted) | EXPERIMENTAL | 600 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) | EXPERIMENTAL | 600 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) | EXPERIMENTAL | 900 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) | EXPERIMENTAL | 600 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) | EXPERIMENTAL | 900 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) | EXPERIMENTAL | 600 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_COMPARATOR | Placebo 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) | EXPERIMENTAL | 900 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_COMPARATOR | Placebo 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) | EXPERIMENTAL | 900 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_COMPARATOR | Placebo 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_COMPARATOR | 600 mg (2 x 300 mg) KVD824 immediate release Capsule dosed orally in fasted state as a single dose |
| Name | Type | Description |
|---|---|---|
| KVD824 Prototype 1 modified-release tablet | DRUG | 300 mg modified-release tablet |
| KVD824 Prototype 2 modified-release tablet | DRUG | 300 mg modified-release tablet |
| KVD824 Immediate-Release Capsule | DRUG | 300 mg immediate-release capsule |
| Placebo to KVD824 Prototype 1 | DRUG | Placebo to 300 mg KVD824 Prototype 1 modified-release tablet |
| KVD824 Prototype 3 modified-release tablet | DRUG | 300 mg modified-release tablet |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | Deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
KVD824 Prototype 1 modified-release is an investigational oral small molecule developed by KalVista Pharmaceuticals for hereditary angioedema, a rare immunological condition marked by recurrent swelling attacks. It is a modified-release tablet formulation designed to alter how the drug is released in the body. It remains in clinical development and is not approved.
KVD824 Prototype 1 modified-release is being studied for hereditary angioedema, a rare inherited disorder characterized by recurrent episodes of swelling in the skin, limbs, gastrointestinal tract, and airways. The Phase 1 work evaluated the formulation in healthy volunteers rather than in patients with the condition.
KalVista Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker KALV, is the developer of KVD824 Prototype 1 modified-release. The company sponsored the Phase 1 pharmacokinetic study of the modified-release formulation conducted in the United Kingdom.
KVD824 Prototype 1 modified-release has completed Phase 1 testing. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory authority for hereditary angioedema or any other indication.
KVD824 Prototype 1 modified-release was evaluated in a single completed Phase 1 trial, NCT05118958. That randomized, double-blind, placebo-controlled crossover study enrolled 37 healthy adult volunteers in the United Kingdom and assessed the pharmacokinetic profile of KVD824 after single and multiple doses of modified-release formulations.
Yes. KVD824 Prototype 1 modified-release tablet is another name for KVD824 Prototype 1 modified-release, the oral modified-release formulation developed by KalVista Pharmaceuticals. Both names refer to the same investigational small molecule candidate studied in the completed Phase 1 pharmacokinetic trial NCT05118958.