NCT07105124

Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject

A Randomized, Open-label, Phase 1 Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	Sibeprenlimab	Sibeprenlimab is being developed for the treatment of immunoglobulin A nephropathy (IgAN), an autoimmune glomerulonephritis characterized by the deposition of immunoglobulin (Ig) A-containing immune complexes in the kidney.

Timeline

• Start date: 2022-10-18
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: China