A Phase 1 interventional study of KVD900 and Placebo to KVD900 in Hereditary Angioedema, sponsored by KalVista Pharmaceuticals, Ltd.. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by KalVista Pharmaceuticals, Ltd. (part of Chiesi Farmaceutici S.p.A.) · Phase 1, Interventional, and Treatment
Among 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. — 1 open to participants now, 1 under way, none of them phase 3. Angioedemas, Hereditary · KalVista Pharmaceuticals, Ltd..
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., this one is the only one that started in 2018, is one of 3 in phase 1, and was the 2nd registered.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
Browse Angioedemas, Hereditary studies →1 of the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. is open now, in 1 country. Recruiting first, the newest first:
KalVista Pharmaceuticals, Ltd. · Sites in United States
By country, each count listing its studies:
Of the 13 Angioedemas, Hereditary studies recruiting now, 9 (69%) set no upper age limit and 4 (31%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 55 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2018.
This study's enrollment of 84 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Median enrollment 84 across the 9 interventional studies, 88 across the 1 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
KalVista Pharmaceuticals, Ltd. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
1 of the studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07654829KalVista Pharmaceuticals, Ltd.Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) | 2027-11-29 |
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
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A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900 · Drug: Placebo to KVD900
Drug: KVD900
Drug: KVD900
Active
Placebo
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.
Pharmacokinetics - Cmax
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-t
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 48 hours post dose
Pharmacokinetics - AUC0-24
Derived from time-concentration plasma levels of KVD900
Time frame: Up to 24 hours post dose
Pharmacokinetics - AUC0-inf
Derived from time-concentration plasma levels of KVD900
Time frame: 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
Time frame: 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
Time frame: Up to 24 hours post dose
Plan to share: No
Ran from Jan 2018 to primary completion in Sep 2018, 8 months.
Of 13 phase 1 interventional studies under Angioedemas, Hereditary, half reached primary completion within 5 months of starting (the median); a quarter within 4 and three quarters within 9. This study's 8 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sebetralstat
KalVista Pharmaceuticals, Ltd. →