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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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