Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2024-07-02

Brief Summary

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This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

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Detailed Description

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The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (SAD) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. This dose-escalating strategy will test the safety of OA-235i when given as a single subcutaneous dosage using up to five successive cohorts. Each cohort will have three non-randomized participants receiving the active medication. One (1) planned multiple dose (MD) randomized, placebo-controlled expansion cohort with 9 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.

Conditions

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Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Single ascending dose (SAD) sequential group study of a sc dose of OA-235i in five (5) planned dose cohorts with 3 subjects/cohort administering a bolus injection at escalating dose levels from 4 to 40 mg. One (1) planned multiple dose (MD), randomized, placebo-controlled expansion cohort with 9 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All subjects will be blinded to IP dose/level in Phase 1a; subjects, Investigator and site staff (excluding unblinded pharmacy staff) will be blinded to IP/placebo in Phase 1b.

Study Groups

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OA-235i (4-40 mg)

Single ascending dose (SAD): OA-235i (4-40 mg) administered subcutaneously (SC) once to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis.

Multiple dose (MD): OA-235i (dose level to be determined from SAD) or placebo administered subcutaneously (SC) once daily for 7 days to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis.

Group Type EXPERIMENTAL

OA-235i (4 mg)

Intervention Type DRUG

3 participants will receive 4 mg as a single subcutaneous dose

OA-235i (8 mg)

Intervention Type DRUG

3 participants will receive 8 mg as a single subcutaneous dose

OA-235i (16 mg)

Intervention Type DRUG

3 participants will receive 16 mg as a single subcutaneous dose

OA-235i (30 mg)

Intervention Type DRUG

3 participants will receive 30 mg as a single subcutaneous dose

OA-235i (40 mg)

Intervention Type DRUG

3 participants will receive 40 mg as a single subcutaneous dose

OA-235i or placebo

Intervention Type DRUG

9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days

Interventions

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OA-235i (4 mg)

3 participants will receive 4 mg as a single subcutaneous dose

Intervention Type DRUG

OA-235i (8 mg)

3 participants will receive 8 mg as a single subcutaneous dose

Intervention Type DRUG

OA-235i (16 mg)

3 participants will receive 16 mg as a single subcutaneous dose

Intervention Type DRUG

OA-235i (30 mg)

3 participants will receive 30 mg as a single subcutaneous dose

Intervention Type DRUG

OA-235i (40 mg)

3 participants will receive 40 mg as a single subcutaneous dose

Intervention Type DRUG

OA-235i or placebo

9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days

Intervention Type DRUG

Other Intervention Names

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PAR2 inhibitor PAR2 inhibitor PAR2 inhibitor PAR2 inhibitor PAR2 inhibitor PAR2 inhibitor placebo

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.
2. 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) \>238 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound ; 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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No