Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05178355 | A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers | PHASE1 | COMPLETED | 108 | — | — | Feb 12, 2019 | Jun 21, 2019 | Feb 17, 2022 | 1 | United Kingdom |
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, Biological NTLA-2002 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat, berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| KalVista Pharmaceuticals, Inc. | KALV | 1 | PHASE3 | KVD900, Drug: KVD900 |
| 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 |