Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, Normal Saline Administration |
| 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 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
KVD824 Prototype 1 modified-release is an investigational small molecule being developed for the treatment of Hereditary Angioedema. It is currently in Phase 1 clinical development. The drug is being studied for its pharmacokinetic profile in healthy subjects, as part of efforts to develop a modified-release formulation for this condition.
KVD824 Prototype 1 modified-release is being developed by KalVista Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KALV. The company is conducting clinical trials to evaluate this investigational drug for Hereditary Angioedema.
KVD824 Prototype 1 modified-release is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial that evaluated its pharmacokinetic profile in healthy subjects.
KVD824 Prototype 1 modified-release has one completed clinical trial, identified as NCT05118958. This Phase 1 crossover study in healthy subjects evaluated the pharmacokinetic profile of KVD824 following single and multiple doses of modified-release formulations. The trial enrolled 37 participants and was conducted in the United Kingdom.
KVD824 Prototype 1 modified-release is a specific formulation of the investigational drug KVD824. The modified-release designation indicates a formulation designed to alter the release profile of the drug. This prototype is being studied in clinical trials for Hereditary Angioedema.