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# KalVista Trial in Hereditary Angioedema on Hold
- URL: https://www.fdaweb.com/kalvista-trial-in-hereditary-angioedema-on-hold/
- Published: 2021-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:55:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149143

FDA has placed a clinical hold on a proposed KalVista Pharmaceuticals Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks. The agency has requested further information and analysis on certain KVD824 preclinical studies submitted to support the planned trial, the company says. Modifications were also proposed for the study protocol, it says, adding that no new studies or new data were requested to begin the Phase 2 trial. KalVistaa describes KVD824 as a twice-daily oral plasma kallikrein inhibitor.  
  
KalVista has previously reported KVD824 data from first-in-human and formulation studies that were conducted in the UK. To date, a total of 121 subjects have received KVD824 as a single dose up to 1,280 mg and up to 14 days of twice-daily dosing of 600 mg and 900 mg. “In both studies adverse event rates were similar in placebo and active arms, no subjects withdrew and no serious adverse events were reported,” the company says.