Aienkang Clinical Medical Research (Beijing) Co., Ltd.

To characterize the pharmacokinetic (PK) profile of CHF6001 after repeated administration of CHF6001 DPI in healthy Chinese subjects.

Primary Study Objectives: The primary efficacy objective of this study is to evaluate the effect of garetosmab (high dose) vs. placebo on the development of new heterotopic ossification (HO) lesions from baseline to week 56 as determined by low-dose computed tomography (CT). The primary safety objective of this study is to evaluate the safety and tolerability of garetosmab (high dose, low dose) vs. placebo from baseline to week 56. Secondary Study Objectives: The key secondary study objectives of this study are to: - Evaluate the effect of garetosmab (high dose) vs. placebo on the number of clinician-assessed acute exacerbations per patient to week 56. - Evaluate the effect of garetosmab (low dose) vs. placebo on the development of new HO lesions from baseline to week 56 as determined by CT. - Evaluate the effect of garetosmab (low dose) vs. placebo on the number of clinician-assessed acute exacerbations per patient to week 56.

To evaluate the effectiveness of adding two doses of CHF6001 to maintenance triple therapy (ICS, LABA, LAMA) in reducing the incidence of moderate to severe exacerbations compared with maintenance triple therapy (i.e. placebo) after 52 weeks of treatment