RecruitingPhase 1NCT07619820

A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)

A Phase 1b, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease Undergoing Dialysis


Sponsor

CSL Behring

Enrollment

24 participants

Start Date

Jun 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CSL300 and Placebo for people with end-stage kidney disease (eskd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCSL300

CSL300 is a humanized anti-interleukin 6 (anti-IL-6) monoclonal antibody (mAb).

OTHERPlacebo

Placebo is a solution for injection matching the excipient content and concentration of the CSL300 product, minus the active ingredient.


Locations(1)

Peking University People's Hospital

Beijing, China

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NCT07619820


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