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

Short Bowel Syndrome Clinical Trial

Official title:
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)

Clinical Trial 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).

Clinical Trial Description

The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04775706
Study type Interventional
Source Hanmi Pharmaceutical Company Limited
Contact Wooyoung Hong
Phone +82 2 410 9238
Email wooyoung.hong@hanmi.co.kr
Status Recruiting
Phase Phase 2
Start date March 3, 2022
Completion date December 2025
View Details
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