A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Status: Recruiting
Location: See all (11) 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 in adult subjects with SBS-associated intestinal failure (SBS-IF).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Men or women, aged 18 years of age or older with intestinal failure resulting in SBS 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 defined as remaining small bowel in continuity of estimated <200 cm (equal to 79 inches) and 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)
Not yet recruiting
Chicago
New York
Mount Sinai School of Medicine
Not yet recruiting
New York
Other Locations
Belgium
UZ Leuven
Not yet recruiting
Leuven
Denmark
Aalborg Universitetshospital
Not yet recruiting
Aalborg
Copenhagen University Hospital
Not yet recruiting
Copenhagen
France
Hopital Beaujon
Recruiting
Clichy
Germany
Asklepios Klinik St. Georg
Recruiting
Hamburg
Universitätsklinikum Tübingen
Recruiting
Tübingen
Poland
Medicome Sp. z o.o.
Recruiting
Oświęcim
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Recruiting
Poznań
Republic of Korea
Samsung Medical Center
Recruiting
Seoul
Contact Information
Primary
Wonkyung Lee
wonkyung.lee@hanmi.co.kr
+82 2 410 9238
Time Frame
Start Date: March 3, 2022
Estimated Completion Date: December 2023
Participants
Target number of participants: 7
Treatments
Experimental: HM15912 0.5 mg/kg Active
Placebo Comparator: Placebo
Authors
Robert E Carroll, Iyer Kishore, Mroziak Beata, Joly-Gomez Francisca, Fusco Stefano, Subramanian Sukanya, Maasberg Sebastian, Matysiak Konrad, Palle Bekker Jeppesen, Lars Vinter-Jensen, Tim Vanuytsel, Jeong-Meen Seo
Related Therapeutic Areas
Sponsors
Leads: Hanmi Pharmaceutical Company Limited

This content was sourced from clinicaltrials.gov

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