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
Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants has provided written informed consent and is willing and able to adhere to all protocol requirements.
• Aged 18 or older, inclusive, at the time of providing written informed consent.
• Diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks before Screening.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+16108784697
Time Frame
Start Date: 2026-06-17
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 24
Treatments
Experimental: CSL300 (Clazakizumab)
Participants will receive CSL300 once every 4 weeks (Q4W) as a slow intravenous (IV) bolus, for a total of 20 weeks during the Treatment Period.
Placebo_comparator: Placebo
Participants will receive a placebo matching to CSL300 Q4W as a slow IV bolus, for a total of 20 weeks during the treatment period.
Related Therapeutic Areas
Sponsors
Leads: CSL Behring