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NOT YET RECRUITING
NCT07757659
PHASE1

Bridging Study of XKH001 in Healthy Adult Caucasian Participants

Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

XKH001 Placebo Injection

Placebo;

Locations (1)

Q-Pharm Pty Limited (also known as Nucleus Network Brisbane)

Melbourne, Australia