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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05711381

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: HM15912	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 2, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Research Center	Tustin	California	United States	92780
2	Panax Clinical Research	Miami Lakes	Florida	United States	33014
3	Clinical Pharmacology of Miami	Miami	Florida	United States	33014
4	AMR Knoxville	Knoxville	Tennessee	United States	37920

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05711381

Other Study ID Numbers:

HM-GLP2-102

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Feb 3, 2023