HM15136: Low dose of HM15136/ High dose of HM15136, SC injection, weekly
Study summary
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.
Eligibility
Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (7)
Facility
City
Region
Status
The Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Otto-von-Guericke-Universitaet Magdeburg
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
More Hanmi Pharmaceutical Company Limited trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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