NCT05711381

Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function

Name: Clinical Trial NCT05711381
Creator: Hanmi Pharmaceutical Company Limited
Keywords: Renal Impairment, HM15912, Phase 1, drug, clinical trial, United States of America

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

Hanmi Pharmaceutical Company Limited·Phase 1·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Renal Impairment
Drug/Device/Intervention: HM15912
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Hanmi Pharmaceutical Company Limited
Location: Tustin,Miami Lakes,Miami,Knoxville, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Dec 02, 2022
End date: Aug 01, 2023
Enrollment: 32 participants

Primary outcome

Maximum serum concentration (Cmax),Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)

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

ICD-10 classifications

Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05711381
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05711381 through Pure Global AI's free database. This Phase 1 trial is sponsored by Hanmi Pharmaceutical Company Limited and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.