A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers

NCT04349800 | Completed Phase 1

• 1 other identifier: KVD900-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.

Conditions

Hereditary Angioedema

Keywords

Sebetralstat

Outcome Measures

Primary Outcomes (5)

• Number of Subjects with Adverse Events

  Change from pre-dose to last visit, 5-7 days post dose.

• Number of Subjects with Serious Adverse Events

  Change from pre-dose to last visit, 5-7 days post dose.

• Number of participants with clinically significant changes in laboratory assessments

  Throughout study until last visit, 5-7 days post dose.

• Number of participants with clinically significant changes in vital signs

  Throughout study until last visit, 5-7 days post dose.

• Number of participants with clinically significant changes in electrocardiogram (ECG) measurements

  Throughout study until last visit, 5-7 days post dose.

Secondary Outcomes (6)

• Pharmacokinetics - Cmax

  Up to 48 hours post dose

• Pharmacokinetics - AUC0-t

  Up to 48 hours post dose

• Pharmacokinetics - AUC0-24

  Up to 24 hours post dose

• Pharmacokinetics - AUC0-inf

  Up to 48 hours post dose

• Pharmacokinetics - food effect (Part C only)

  Up to 24 hours post dose

Study Arms (10)

Single Ascending Dose - 5 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 10 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 20 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 40 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 80 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 160 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 300 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Single Ascending Dose - 600 mg

EXPERIMENTAL

Drug: KVD900; Drug: Placebo to KVD900

Formulation Screen

EXPERIMENTAL

Drug: KVD900

Food Effect

EXPERIMENTAL

Drug: KVD900

Interventions

KVD900 DRUG

Active

Food Effect; Formulation Screen; Single Ascending Dose - 10 mg; Single Ascending Dose - 160 mg; Single Ascending Dose - 20 mg; Single Ascending Dose - 300 mg; Single Ascending Dose - 40 mg; Single Ascending Dose - 5 mg; Single Ascending Dose - 600 mg; Single Ascending Dose - 80 mg

Placebo to KVD900 DRUG

Placebo

Single Ascending Dose - 10 mg; Single Ascending Dose - 160 mg; Single Ascending Dose - 20 mg; Single Ascending Dose - 300 mg; Single Ascending Dose - 40 mg; Single Ascending Dose - 5 mg; Single Ascending Dose - 600 mg; Single Ascending Dose - 80 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
• 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.

Sponsors & Collaborators

• KalVista Pharmaceuticals, Ltd.: lead

Study Sites (1)

KalVista Investigative Site

Wales, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35086692 DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

sebetralstat

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 16, 2020
• Study Start: January 4, 2018
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)