Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KVD824 · 1 trial · 1 indication
Number of Subjects with Treatment Emergent Adverse Events
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in laboratory assessments
Number of subjects who had any increase in QTcF parameters.
| Arm | Type | Description |
|---|---|---|
| Part A - KVD824 - 10 mg | EXPERIMENTAL | 6 participants were administered10 mg of KVD824 in capsule form (1 x 10 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 20 mg | EXPERIMENTAL | 6 participants were administered 20mg of KVD824 in capsule form ( 2 x 10 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 40 mg | EXPERIMENTAL | 6 participants were administered 40mg of KVD824 in capsule form (1 x 40 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 80 mg | EXPERIMENTAL | 6 participants were administered 80mg of KVD824 in capsule form (2 x 40 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 160mg | EXPERIMENTAL | 6 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 320 mg | EXPERIMENTAL | 6 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 640 mg | EXPERIMENTAL | 6 participants were administered 640 mg of KVD824 in capsule form (2 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 1280 mg | EXPERIMENTAL | 6 participants were administered 1280 mg of KVD824 in capsule form (4 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part B - KVD824 - 80 mg Multi-Dose | EXPERIMENTAL | 6 participants were administered 80 mg of KVD824 in capsule form (2 x 40 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 160 mg Multi-Dose | EXPERIMENTAL | 6 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 320 mg Multi-Dose | EXPERIMENTAL | 6 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 640 mg Multi-Dose | EXPERIMENTAL | 6 participants were administered 640mg of KVD824 in capsule form (2 x 320 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part C - KVD824 - 320 mg Fasted | EXPERIMENTAL | 12 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 in a fasted state. |
| Part C - KVD824 - 320 mg High fat breakfast | EXPERIMENTAL | 12 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 following consumption of a high fat breakfast. |
| Name | Type | Description |
|---|---|---|
| KVD824 | DRUG | Active |
| Placebo to KVD824 | DRUG | Placebo |
Inclusion Criteria: * Healthy male subjects between 18 and 55 years of age. * Healthy subjects as determined by past medical history and as judged by the Chief Investigator / deputy. * Male subject willing to wear a condom and whose partner of child bearing potential uses a highly effective method ...
| 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 is an investigational small molecule being developed for the treatment of Hereditary Angioedema, a condition characterized by recurrent episodes of severe swelling. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
KVD824 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its potential role in managing Hereditary Angioedema, though the exact mechanism of action remains unspecified.
KVD824 is being developed by KalVista Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KALV. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug.
KVD824 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug remains under evaluation for its safety, tolerability, and pharmacokinetic profile.
KVD824 has one completed Phase 1 clinical trial registered as NCT05178355. This study evaluated single and multiple doses of KVD824 in healthy volunteers, assessing safety, tolerability, pharmacokinetics, and the effect of food. The trial enrolled 108 participants in the United Kingdom.
KVD824 is a unique investigational compound developed by KalVista Pharmaceuticals. No alternative names have been reported for this drug, and it is not known to be identical to any other approved or investigational medication.