Congenital Hyperinsulinism Clinical Trial
Official title:
A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility | Inclusion Criteria: - Male and female subjects aged =2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation - Stable therapy with SoC medications with or without nutritional supplementation - Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery - HbA1c <7% Exclusion Criteria: - Subjects with type 1 or type 2 diabetes mellitus - Other reasons for hypoglycemia, including but not limited to drug-induced hyperinsulinemic hypoglycemia, etc - Treatment of CHI with continuous intravenous glucose or glucagon infusion within 3 months prior to screening - Subjects with current use of any drugs that are known to interfere with the study drug, glucose metabolism, or study procedures (eg, use of systemic glucocorticoids [excluding topical, intra-articular or ophthalmic application, nasal spray, or inhaled forms] or insulin) - Have conditions that could affect glucose levels such as pheochromocytoma, insulinoma, and glucagonoma |
Country | Name | City | State |
---|---|---|---|
Germany | Otto-von-Guericke-Universitaet Magdeburg | Magdeburg | |
Israel | Hadassah Medical Center (HMC) | Jerusalem | |
United Kingdom | Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust | London | |
United Kingdom | Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health | Manchester | |
United States | University of California Los Angeles | Los Angeles | California |
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
United States, Germany, Israel, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 | after multiple subcutaneous (SC) doses of 8 weeks | ||
Primary | Number of incidence of clinical laboratory abnormalities | after multiple subcutaneous (SC) doses of 8 weeks | ||
Primary | Maximum Serum Concentration [Cmax] | after multiple subcutaneous (SC) doses of 8 weeks | ||
Primary | Time to reach Cmax | after multiple subcutaneous (SC) doses of 8 weeks |
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