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)

Hanmi Pharmaceutical Company Limited27 个研究点分布在 8 个国家目标入组 18 人2022年3月3日

适应症Short Bowel Syndrome

干预措施HM15912 Active Placebo

概览

阶段: 2 期
干预措施: HM15912 Active
疾病 / 适应症: Short Bowel Syndrome
发起方: Hanmi Pharmaceutical Company Limited
入组人数: 18
试验地点: 27
主要终点: Incidence of adverse events (AEs)
状态: 招募中
最后更新: 4天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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).

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2022年3月3日

结束日期

2028年5月1日

最后更新

4天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Hanmi Pharmaceutical Company Limited

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•Any history of colon cancer.
•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
•History of alcohol or drug abuse (within 1 year of screening)