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 objective: To evaluate the pharmacokinetics of beclomethasone formoterol powder for inhalation in healthy Chinese subjects after a single administration at different dose levels. Secondary objective: To evaluate the safety profile of beclomethasone formoterol powder for inhalation in healthy Chinese subjects after a single administration at different dose levels.

The main purpose of the study is to demonstrate, through a 52-week blinded period, the efficacy and safety of belimumab 10 mg/kg added to standard treatment compared with placebo in patients with SLE. The evaluation indicator is the SLE Responder Index (SRI) at week 52, which is defined as a composite response endpoint: including SELENA SLEDAI score, Physician Global Assessment (PGA) and BILAG A and B organ item scores; and to demonstrate the long-term safety and tolerability of belimumab in Chinese SLE subjects through an open-label period.