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NCT05711381
Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function
Conditions: Renal Impairment
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: Hanmi Pharmaceutical Company Limited
Location: United States
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
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 proceduresMales and females ≥ 18 and ≤ 80 years of age at the Screening visitBody mass index of ≥ 17.5 and ≤ 40.0 kg/m2Meet 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 dialysisSubjects 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 subjectEvidence of any viral (including COVID-19), bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to the Screening visit
Source: ClinicalTrials.gov (NCT05711381). StuddyBuddy aggregates publicly available trial information.