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

Description

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).

Conditions

Short Bowel Syndrome

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Short Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois Hospital & Health Sciences System (UI Health), Chicago, Illinois, United States, 60612

Boston

Brigham & Women's Hospital, Boston, Massachusetts, United States, 02115

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hanmi Pharmaceutical Company Limited,

Study Record Dates

2028-05