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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Low dose of HM15136/ High dose of HM15136, SC injection, weekly
University of California Los Angeles
Los Angeles, California, United States
RECRUITINGThe Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGOtto-von-Guericke-Universitaet Magdeburg
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Number of incidence of clinical laboratory abnormalities
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Maximum Serum Concentration [Cmax]
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
Time to reach Cmax
Time frame: after multiple subcutaneous (SC) doses of 8 weeks
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Magdeburg, Germany
Hadassah Medical Center (HMC)
Jerusalem, Israel
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGGreat Ormond Street Hospital (GOSH) for Children NHS Foundation Trust
London, United Kingdom
RECRUITINGCentral Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health
Manchester, United Kingdom
RECRUITING