PL-8177 for Ulcerative Colitis
(PL8177-205 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).
Who Is on the Research Team?
Robert Jordan, VP Clinical Operations
Principal Investigator
Telephone: 609-598-1786; Email: rjordan@palatin.com
Are You a Good Fit for This Trial?
Adults aged 18-75 with active Ulcerative Colitis (UC) for at least 6 months, confirmed by endoscopy and fecal calprotectin levels. Participants must not have had certain UC treatments recently, agree to contraception if of childbearing potential, and cannot have a history of significant other diseases or colon surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PL8177 or placebo for 8 weeks to evaluate safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PL8177
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Palatin Technologies, Inc
Lead Sponsor