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

April 25, 2025 updated by: KalVista Pharmaceuticals, Ltd.

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of KVD900 Followed by Crossover Sub-studies of KVD900 Formulations, and Food Effect in Healthy Male Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Ascending Dose - 5 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 10 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 20 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 40 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 80 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 160 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 300 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Single Ascending Dose - 600 mg
Drug: KVD900
Active
Drug: Placebo to KVD900
Placebo
Experimental: Formulation Screen
Drug: KVD900
Active
Experimental: Food Effect
Drug: KVD900
Active

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Subjects with Adverse Events
Time Frame: Change from pre-dose to last visit, 5-7 days post dose.
Change from pre-dose to last visit, 5-7 days post dose.
Number of Subjects with Serious Adverse Events
Time Frame: Change from pre-dose to last visit, 5-7 days post dose.
Change from pre-dose to last visit, 5-7 days post dose.
Number of participants with clinically significant changes in laboratory assessments
Time Frame: Throughout study until last visit, 5-7 days post dose.
Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in vital signs
Time Frame: Throughout study until last visit, 5-7 days post dose.
Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements
Time Frame: Throughout study until last visit, 5-7 days post dose.
Throughout study until last visit, 5-7 days post dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Cmax
Time Frame: Up to 48 hours post dose
Derived from time-concentration plasma levels of KVD900
Up to 48 hours post dose
Pharmacokinetics - AUC0-t
Time Frame: Up to 48 hours post dose
Derived from time-concentration plasma levels of KVD900
Up to 48 hours post dose
Pharmacokinetics - AUC0-24
Time Frame: Up to 24 hours post dose
Derived from time-concentration plasma levels of KVD900
Up to 24 hours post dose
Pharmacokinetics - AUC0-inf
Time Frame: Up to 48 hours post dose
Derived from time-concentration plasma levels of KVD900
Up to 48 hours post dose
Pharmacokinetics - food effect (Part C only)
Time Frame: Up to 24 hours post dose
90% confidence intervals of the ratios for AUC0-t and Cmax with and without food lie in the range 80-125
Up to 24 hours post dose
Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)
Time Frame: Up to 24 hours post dose
90% confidence intervals of the ratios for AUC0-t and Cmax between the two dosages lie in the range 80-125
Up to 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KalVista Pharmaceuticals, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KVD900-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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