A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• 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.
Locations
United States
Illinois
University of Illinois Hospital & Health Sciences System (UI Health)
RECRUITING
Chicago
Massachusetts
Brigham & Women's Hospital
RECRUITING
Boston
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Denmark
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
RECRUITING
Copenhagen
France
Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Bordeaux
Hopital Beaujon
RECRUITING
Clichy
Les Hospices Civils de Lyon
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nice
RECRUITING
Nice
Germany
Asklepios Klinik St. Georg
RECRUITING
Hamburg
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Poland
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny w Poznaniu Uniwersytecki Osrodek Wczesnych Faz Ul. Długa 1 /2
RECRUITING
Poznan
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Wooyoung Hong
wooyoung.hong@hanmi.co.kr
+82 2 410 9238
Time Frame
Start Date:2022-03-03
Estimated Completion Date:2028-05
Participants
Target number of participants:18
Treatments
Experimental: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active