NCT05711381

Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912(Sonefpeglutide) in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function

Detailed description

A single-dose, open-label, Phase 1 study (HM-GLP2-102) was conducted to evaluate the impact of renal impairment (RI) on the pharmacokinetics (PK) of HM15912. This study aimed to assess the safety and PK profile of HM15912 at a minimum effective dose of 0.5 mg/kg, which was determined based on findings from a previous clinical study (HM-GLP2-101). The study was initially designed to be conducted in two parts. Part 1: An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with severe RI and subjects with normal renal function as a control group. Part 2 (if applicable): An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with moderate and mild RI.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	HM15912	Singe subcutaneous administration of HM15912 0.5 mg/kg

Timeline

• Start date: 2022-12-02
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2023-02-03
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study