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Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

RecruitingPhase 2

Sponsor: Hanmi Pharmaceutical Company Limited

Conditions: Short Bowel Syndrome

Interventions: HM15912 Active, Placebo

Countries: United States, Belgium, Denmark, France, Germany, Poland, South Korea, United Kingdom

This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (15)

Boston, Massachusetts, United States
Cleveland, Ohio, United States
Leuven, Vlaams Brabant, Belgium
Copenhagen, Denmark
Clichy, Clichy, France
Bordeaux, France
Lyon, France
Nice, France
Hamburg, Free and Hanseatic City of Hamburg, Germany
Tübingen, Tübingen, Germany
Skawina, Lesser Poland Voivodeship, Poland
Lodz, Łódź Voivodeship, Poland
Seoul, South Korea
Salford, Greater Manchester, United Kingdom
London, United Kingdom