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

KalVista Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hereditary Angioedema

Treatments: Drug: Placebo to KVD900; Drug: KVD900

Study type: Interventional

Funder types: Industry

Identifiers

NCT04349800

KVD900-101

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

84 participants in 10 patient groups

Single Ascending Dose - 5 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 10 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 20 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 40 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 80 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 160 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 300 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Single Ascending Dose - 600 mg

Experimental group

Treatment:

Drug: KVD900

Drug: Placebo to KVD900

Formulation Screen

Experimental group

Treatment:

Drug: KVD900

Food Effect

Experimental group

Treatment:

Drug: KVD900