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HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04732416
Study type Interventional
Source Hanmi Pharmaceutical Company Limited
Contact JinHee Byeon
Phone +82 2 410 0485
Email jinhee.byeon@hanmi.co.kr
Status Recruiting
Phase Phase 2
Start date October 28, 2021
Completion date March 31, 2025
View Details
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