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

Primary Purpose

Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HM15912
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orange County Research CenterRecruiting
  • Panax Clinical ResearchRecruiting
  • Clinical Pharmacology of MiamiRecruiting
  • AMR KnoxvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Severe renal impairment

Normal renal impairment

Moderate renal impairment

Mild renal impairment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
June 14, 2023
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05711381
Brief Title
Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Title
Normal renal impairment
Arm Type
Experimental
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Title
Mild renal impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HM15912
Intervention Description
Drug: HM15912 Active 0.5mg/kg
Primary Outcome Measure Information:
Title
Maximum serum concentration (Cmax)
Time Frame
Day 1 to 29 (Total duration: 29 days)
Title
Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)
Time Frame
Day 1 to 29 (Total duration: 29 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soohyun Kim
Phone
+82 2 410 0470
Email
soohyun.kim0810@hanmi.co.kr
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, Dr
First Name & Middle Initial & Last Name & Degree
Joel Neutel, Dr
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Perry, Dr.
First Name & Middle Initial & Last Name & Degree
Robert Perry, Dr.
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Rondon, Dr
First Name & Middle Initial & Last Name & Degree
Juan Rondon, Dr
Facility Name
AMR Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Smith, Dr.
First Name & Middle Initial & Last Name & Degree
William Smith, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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