Hereditary AngioedemaPhase 1NCT04349800
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
A Phase 1 study testing KVD900 in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United Kingdom.
Trial summary
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD900
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2018to 10 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD900, Placebo to KVD900
- Keywords
- Sebetralstat
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD900Drug
Active
Placebo to KVD900Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose - 5 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 10 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 20 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 40 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 80 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 160 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 300 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Single Ascending Dose - 600 mg | Experimental | Not described Receives: Drug: KVD900; Drug: Placebo to KVD900 |
| Formulation Screen | Experimental | Not described Receives: Drug: KVD900 |
| Food Effect | Experimental | Not described Receives: Drug: KVD900 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Adverse Events
Measured: Change from pre-dose to last visit, 5-7 days post dose.
Number of Subjects with Serious Adverse Events
Measured: Change from pre-dose to last visit, 5-7 days post dose.
Number of participants with clinically significant changes in laboratory assessments
Measured: Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in vital signs
Measured: Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements
Measured: Throughout study until last visit, 5-7 days post dose.
Secondary outcomes (6)
Pharmacokinetics - Cmax
Derived from time-concentration plasma levels of KVD900
Measured: Up to 48 hours post dose
Pharmacokinetics - AUC0-t
Derived from time-concentration plasma levels of KVD900
Measured: Up to 48 hours post dose
Pharmacokinetics - AUC0-24
Derived from time-concentration plasma levels of KVD900
Measured: Up to 24 hours post dose
Pharmacokinetics - AUC0-inf
Derived from time-concentration plasma levels of KVD900
Measured: Up to 48 hours post dose
Pharmacokinetics - food effect (Part C only)
90% confidence intervals of the ratios for AUC0-t and Cmax with and without food lie in the range 80-125
Measured: Up to 24 hours post dose
Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)
90% confidence intervals of the ratios for AUC0-t and Cmax between the two dosages lie in the range 80-125
Measured: Up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start4 Jan 2018
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349800
- Sponsor's protocol ID
- KVD900-101
- Status last verified
- Apr 2025
- First submitted
- 9 Mar 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35086692
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04349800
- Acronym / sponsor ID
- KVD900-101
- Conditions
- Hereditary Angioedema
- Keywords
- Sebetralstat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KVD900Active | Drug | 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 KVD900Placebo | Drug | 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 |
Primary outcome
Number of Subjects with Adverse Events
Time frame: 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.
Number of participants with clinically significant changes in laboratory assessments
Time frame: 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.
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements
Time frame: Throughout study until last visit, 5-7 days post dose.
6 secondary outcomes
Pharmacokinetics - Cmax
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-t
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-24
Time frame: Up to 24 hours post dose
Pharmacokinetics - AUC0-inf
Time frame: Up to 48 hours post dose
Pharmacokinetics - food effect (Part C only)
Time frame: Up to 24 hours post dose
Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)
Time frame: Up to 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 35086692Maetzel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KVD900 in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Adverse Events (time frame: Change from pre-dose to last visit, 5-7 days post dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.