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

NCT05680233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

OA-235i (4 mg)

3 participants will receive 4 mg as a single subcutaneous dose

DRUG

OA-235i (8 mg)

3 participants will receive 8 mg as a single subcutaneous dose

DRUG

OA-235i (16 mg)

3 participants will receive 16 mg as a single subcutaneous dose

DRUG

OA-235i (30 mg)

3 participants will receive 30 mg as a single subcutaneous dose

DRUG

OA-235i (40 mg)

3 participants will receive 40 mg as a single subcutaneous dose

DRUG

OA-235i or placebo

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    collaborator OTHER

  • Oasis Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Athan Kuliopulos, MD, PhD · Oasis Pharmaceuticals, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2024-07-02
Completion
2024-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680233 on ClinicalTrials.gov