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.
Age range
2 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0
Timeframe: after multiple subcutaneous (SC) doses of 8 weeks
Number of incidence of clinical laboratory abnormalities
Timeframe: after multiple subcutaneous (SC) doses of 8 weeks
Maximum Serum Concentration [Cmax]
Timeframe: after multiple subcutaneous (SC) doses of 8 weeks
Time to reach Cmax
Timeframe: after multiple subcutaneous (SC) doses of 8 weeks