A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
NCT ID: NCT04349800
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2018-01-04
2018-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single Ascending Dose - 5 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 10 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 20 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 40 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 80 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 160 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 300 mg
KVD900
Active
Placebo to KVD900
Placebo
Single Ascending Dose - 600 mg
KVD900
Active
Placebo to KVD900
Placebo
Formulation Screen
KVD900
Active
Food Effect
KVD900
Active
Interventions
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KVD900
Active
Placebo to KVD900
Placebo
Eligibility Criteria
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Inclusion Criteria
* Healthy subjects as determined by past medical history and as judged by the Chief Investigator or designee.
* Male subject willing to use a highly effective method of contraception.
* Subject with a body mass index (BMI) of 18-32 kg/m2.
* Subject with no clinically significant history of previous allergy or sensitivity to KVD900 or any of the excipients contained within the investigational medicinal product (IMP).
* Subject with no clinically significant abnormal serum biochemistry, haematology, clotting profiles, and urine examination values within 28 days before the first dose of IMP.
* Subject with a negative urinary drugs of abuse screen, determined within 28 days before the first dose of IMP
* Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
* Subject with no clinically significant abnormalities in 12-lead electrocardiogram
* Subjects must not donate sperm from first dose until at least 3 months after last dose of IMP.
* Subjects without any special food restrictions that would hinder ability to consume the high fat breakfast provided during study Part C; such as lactose intolerance , vegan, low-fat, low sodium, etc.
* Subjects with no known allergy or sensitivity to lactose and/or any additional excipients contained in IMP.
* Subject must be available to complete the study (including all follow up visits).
* Subject must satisfy the Chief Investigator or designee about their fitness to participate in the study.
* Subject must provide written informed consent to participate in the study.
Exclusion Criteria
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular (no history of syncope or vasovagal events), or metabolic dysfunction.
* Subjects with a history of clotting abnormalities.
* A clinically significant history of drug or alcohol abuse in the last 5 years.
* Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to dosing with the study medication or users of cigarette replacements.
* Inability to communicate well with Investigators.
* Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP.
* Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
18 Years
55 Years
MALE
Yes
Sponsors
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KalVista Pharmaceuticals, Ltd.
INDUSTRY
Responsible Party
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Locations
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KalVista Investigative Site
Wales, , United Kingdom
Countries
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References
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Maetzel A, Smith MD, Duckworth EJ, Hampton SL, De Donatis GM, Murugesan N, Rushbrooke LJ, Li L, Francombe D, Feener EP, Yea CM. KVD900, an oral on-demand treatment for hereditary angioedema: Phase 1 study results. J Allergy Clin Immunol. 2022 Jun;149(6):2034-2042. doi: 10.1016/j.jaci.2021.10.038. Epub 2022 Jan 24.
Other Identifiers
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KVD900-101
Identifier Type: -
Identifier Source: org_study_id
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