Nonalcoholic Steatohepatitis Clinical Trial
Official title:
A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OA-235i, a PAR2 Inhibitor, in Adults With Nonalcoholic Steatohepatitis
This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
Status | Recruiting |
Enrollment | 23 |
Est. completion date | April 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Main Inclusion Criteria: 1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening. 2. Body mass index (BMI) of =25 and <40 kg/m2 with a total body weight 50-150 kg (inclusive) at Screening and Day 1 Pre-dose. 3. Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following: 1. Histologically with liver biopsy within 2 years prior to Screening (documentation with pathology report); or 2. Radiologically with =5% steatosis measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), or controlled attenuation parameter (CAP) >288 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound within 1 year prior to Screening; or 3. Clinically with a diagnosis of Metabolic Syndrome (MetS) reflecting the presence of at least 3 of 5 factors/criteria (ie, abdominal obesity, elevated triglycerides, reduced HDL-C, elevated blood pressure, and/or elevated fasting glucose [IFG or type 2 diabetes mellitus]) as defined by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) [Grundy 2005]; and fatty liver on imaging within 1 year prior to Screening. Key Exclusion Criteria: 1. History or presence of cirrhosis as assessed by Investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory). 2. Clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.). 3. History or presence of other concomitant liver disease (eg, hepatitis B & C, alcoholic liver disease, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin (A1AT) deficiency, bile duct obstruction, liver primary or metastatic cancer, drug-induced liver disease. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Oasis Pharmaceuticals, LLC | Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment-emergent with adverse events (incidence and severity) | 30 Days | |
Secondary | To characterize the OA-235i Pharmacokinetics (PK) by Cmax | OA-235i PK by peak plasma concentration (Cmax) | 8 Days | |
Secondary | To characterize the OA-235i Pharmacokinetics (PK) by t1/2 | OA-235i PK by the terminal elimination half-life (t1/2) | 8 Days | |
Secondary | To characterize the OA-235i Pharmacokinetics (PK) by Tmax | OA-235i PK by time to peak plasma concentration (Tmax) | 8 Days | |
Secondary | To characterize the OA-235i Pharmacokinetics (PK) by AUC | OA-235i PK by area under the plasma concentration versus time curve (AUC) | 8 Days |
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