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

NCT05711381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-04

Study results available
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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

Conditions

  • Renal Impairment

Interventions

DRUG

HM15912

Singe subcutaneous administration of HM15912 0.5 mg/kg

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2023-08-15
Completion
2023-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711381 on ClinicalTrials.gov