Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function

Phase 1

Waitlist Available

Research Sponsored by Sinovent Pty Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 10 days post-dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of three drugs given to adults with different levels of kidney function. The goal is to see how safe the drugs are. The drugs work together to treat infections, with one drug helping another work better.

Eligible Conditions

Moist Dressings Over Meshed Autografts
Bacterial Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 10 days post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 10 days post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 10 days post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adverse event (include SAEs) will be assessed and categorized.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 5: End-stage renal disease (ESRD) receiving hemodialysis (HD) therapyExperimental Treatment1 Intervention

Participants with ESRD receiving HD therapy at least 3 times a week for at least 3 months prior to Screening visit receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg

Group II: Cohort 4: Severe renal insufficiencyExperimental Treatment1 Intervention

Participants with an eGFR 15 to \<30 mL/min/1.73m2 receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg

Group III: Cohort 3: Moderate renal insufficiencyExperimental Treatment1 Intervention

Participants with an eGFR 30 to \<60 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg

Group IV: Cohort 2: Mild renal insufficiencyExperimental Treatment1 Intervention

Participants with an eGFR 60 to \<90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg

Group V: Cohort 1: normal renal functionExperimental Treatment1 Intervention

Participants with an eGFR ≥ 90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug