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NOT YET RECRUITING
NCT07619820
PHASE1

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

Sponsor: CSL Behring

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-30

Completion Date

2027-11-30

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

CSL300

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

OTHER

Placebo

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