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

NCT07619820 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • End Stage Kidney Disease (ESKD)

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.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-17
Primary Completion
2027-08-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619820 on ClinicalTrials.gov