Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Feb 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HM15912 for adults with Short Bowel Syndrome (SBS), a condition that can lead to severe intestinal problems and requires special nutritional support. The trial is designed to find out if this treatment is safe and how it works in the body. It involves giving some participants the treatment and others a placebo (a treatment that looks the same but has no active ingredients) without anyone knowing which they are receiving. The goal is to gather important information about the treatment's safety and effectiveness for people living with SBS-related intestinal failure.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of SBS with intestinal failure. You should have had any necessary surgery at least six months before joining the study and should not have any further surgeries planned during the trial. There are some health conditions that could exclude you from participating, such as a history of certain cancers or substance abuse. If eligible, you can expect to be closely monitored throughout the study, and you'll receive guidance from the medical team to ensure your safety and comfort. This trial is currently recruiting participants, so it could be an opportunity for those looking for new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is \<18 years)
• • 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• • 3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.
• Exclusion Criteria:
• • 1. Any history of colon cancer.
• • 2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
• • 3. History of alcohol or drug abuse (within 1 year of screening)