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

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

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

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: HM15912

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Soohyun Kim; Phone Number: +82 2 410 0470; Email: soohyun.kim0810@hanmi.co.kr

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • AMR Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject voluntairly agrees to participate in this study and sign an IRB-approved informed consent prior to perfomring any of the Screening visit procedures
• Males and females ≥ 18 and ≤ 80 years of age at the Screening visit
• Body mass index of ≥ 17.5 and ≤ 40.0 kg/m2
• Meet the following eGFR criteria during the screening period based on the CKD-EPI equation: Severe renal imapriment: eGFR < 30 mL/min/1.73m2 but not requiring hemodialysis. Moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR < 60 mL/min/1.73m2, Normal renal function (eGFR ≥ 90 mL/min/1.73m2)

Exclusion Criteria:

• Renal transplant recipients or subjects requiring hemodialysis and peritoneal dialysis
• Subjects with a history or presence of any psychiatric disoerder that, in the opion of the investigator, might confound the results of the study or pose addiitonal risk in administering the IP to the subject
• Evidence of any viral (including COVID-19), bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to the Screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild renal impairment	Drug: HM15912; Drug: HM15912 Active 0.5mg/kg
Experimental: Moderate renal impairment	Drug: HM15912; Drug: HM15912 Active 0.5mg/kg
Experimental: Severe renal impairment	Drug: HM15912; Drug: HM15912 Active 0.5mg/kg
Experimental: Normal renal impairment	Drug: HM15912; Drug: HM15912 Active 0.5mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum serum concentration (Cmax)	Day 1 to 29 (Total duration: 29 days)
Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)	Day 1 to 29 (Total duration: 29 days)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: HM-GLP2-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No