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Bridging Study of XKH001 in Healthy Adult Caucasian Participants
Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD
Summary
This is a Phase Id, randomised, double-blind, placebo-controlled, multiple-dose, bridging study conducted at a single Phase I clinical research unit in Australia. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of XKH001 following repeated subcutaneous administration in healthy adult Caucasian participants, and to provide an ethnic-bridging pharmacokinetic comparison with the prior Phase I dataset in Chinese participants, required for XKH001's global development programme.
Official title: A Phase Id, Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Bridging Study To Evaluate The Pharmacokinetics, Safety, Tolerability, and Immunogenicity of XKH001 in Healthy Adult Caucasian Participants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
2
Start Date
2026-08-01
Completion Date
2027-08-01
Last Updated
2026-08-11
Healthy Volunteers
Yes
Conditions
Interventions
XKH001 Injection
XKH001, developed by Zhejiang Kanova Biopharmaceutical Co., Ltd., is a recombinant anti-IL-25 humanized IgG1 monoclonal antibody (mAb) composed of two identical light chains and two identical heavy chains linked by disulfide bonds. Each light chain consists of 215 amino acids, and each heavy chain consists of 455 amino acids, for a total of 1340 amino acids.
XKH001 Placebo Injection
Placebo;
Locations (1)
Q-Pharm Pty Limited (also known as Nucleus Network Brisbane)
Melbourne, Australia