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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

Inclusion Criteria:

1. 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)

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 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.

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)