Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04736966
Phase
PHASE1
Status
Completed

Conditions

  • Alcoholic Liver Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab 30mg — DRUG
    30mg of Guselkumab administered by subcutaneous injection
  • Guselkumab 70mg — DRUG
    70mg of Guselkumab administered by subcutaneous injection
  • Guselkumab 100mg — DRUG
    100mg of Guselkumab administered by subcutaneous injection

Study Details

A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease

Key Dates

Start date
Mar 3, 2021
Status verified
Aug 2024
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab 30mg
    Guselkumab administered by subcutaneous injection at Day 1 and Day 29
  • Experimental: Guselkumab 70 mg
    Guselkumab administered by subcutaneous injection at Day 1 and Day 29
  • Experimental: Guselkumab 100mg
    Guselkumab administered by subcutaneous injection at Day 1 and Day 29

Primary Outcome Measure

Assess the safety and tolerability of Guselkumab [ Time Frame: 48 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego· La Jolla, CA

Related Studies