Clinical trials

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.

This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.

This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.