Healthy
Conditions
Keywords
Healthy, Subjects, Safety, Tolerability, VBY891, Maximum, Pharmacodynamic, Pharmacokinetic
Brief summary
Psoriasis is an inflammatory autoimmune disease that might be controlled by a cathepsin S inhibitor like VBY-891.
Detailed description
Refer to Brief Summary
Interventions
DRUGVBY-891
Cathepsin S inhibitor
DRUGPlacebo
Sponsors
LEO Pharma
Virobay Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18-60 years old * Screening body mass index between 18-32 kg/m2 * Good health, no clinically significant findings in medical history, 12-lead ECG, & vital signs; * Clinical lab evaluations (Chem panel \[fasted at least 8 hrs\], CBC, HbA1c & UA in reference range for test lab (unless deemed not clinically significant); * Negative test for drugs of abuse at Screening & at Check-in (includes alcohol); * Negative hepatitis, HIV & TB screens; * Females non-pregnant, non-lactating, & either postmenopausal for at least 1 year, surgically sterile for at least 90 days prior to Check-in, or agree to use from the time of consent until 90 days after Study Completion an effective form of contraception. For all females, a pregnancy test result must be negative at Screening & Check-in. * Males will be sterile or agree to use from Check-in until 90 days following discharge an effective method of contraception. * Able to comprehend & willing to sign Informed Consent Form
Exclusion criteria
* Females pregnant or nursing, or childbearing potential but unwilling to use contraception. * History of renal or hepatic impairment; stomach or intestinal surgery or resection, malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would alter absorption &/or excretion of orally administered drugs (appendectomy or hernia repair allowed); * Anemia (hemoglobin \<11.5 g/dL for females; \< 13 g/dL for males) or blood donation within 8 weeks of Check-in; * Plasma donation within 4 weeks of Check-in; * History of alcoholism or drug addiction within 6 months to Check-in; * Use of drugs of abuse or prescription drugs for recreational use 6 months prior to Check-in; * Use of any tobacco-containing or nicotine-containing products 6 months prior to Check-in & during study; * Participation in another drug trial 30 days of Check-in (within 8 weeks if previous investigational drug has immunomodulatory effects, other than cathepsin S inhibition); * History or clinical manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders * History of hypersensitivity or allergies to any drug compound * History or presence of abnormal ECG * Laboratory abnormality deemed clinically significant; * Use of or inability to discontinue any prescription medications/products 14 days prior to Check-in & during study; * Use of certain over-the-counter, non-prescription preparations are permitted up to 3 days before first dose; * Use of alcohol-containing, grapefruit-containing, star fruit containing foods or beverages or energy drinks 72 hours to Check-in & during study; * Poor peripheral venous access; * Receipt of blood products 6 months to Check-in * Subjects with history of Gilbert's Syndrome; * Strenuous activities 48 hours to Check-in * Illness 5 days to drug administration * Any acute or chronic condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of VBY-891 | For 7 days (single dose) or 17 days (multiple dose) | Compare number of adverse events experienced by male versus female subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VBY-891 Blood Levels | 3 days (single dose) or 10 days (multiple dose) | Assessment of VBY-891 levels in blood after single or multiple doses |
Other
| Measure | Time frame | Description |
|---|---|---|
| Iip10 Accumulation and Cathepsin S Protein Level | 24 hours | Iip10 accumulation and cathepsin S protein level by Mass Spectrophotometry to determine inhibition of cathepsin S activity |
Countries
United States
Outcome results
None listed