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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15136 active | Experimental | Cohort 1 / Cohort 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15136 | Drug | Low dose of HM15136/ High dose of HM15136, SC injection, weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 | after multiple subcutaneous (SC) doses of 8 weeks | |
| Number of incidence of clinical laboratory abnormalities | after multiple subcutaneous (SC) doses of 8 weeks | |
| Maximum Serum Concentration [Cmax] | after multiple subcutaneous (SC) doses of 8 weeks | |
| Time to reach Cmax | after multiple subcutaneous (SC) doses of 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Otto-von-Guericke-Universitaet Magdeburg |
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| Magdeburg |
| Germany |
| Hadassah Medical Center (HMC) | Jerusalem | Israel |
| Pusan National University Yangsan Hospital | Pusan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| 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 Kingdom |
| ID | Term |
|---|---|
| D044903 | Congenital Hyperinsulinism |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |
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| ID | Term |
|---|---|
| C000726310 | HM15136 |
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