[Translation] An evaluation of CZ4D inhalation powder in healthy subjects in a single ascending dose (Part 1), in patients with mild stable asthma in multiple ascending doses (Part 2), and in patients with mild to moderate stable asthma in a two-cycle, crossover design (Part 3) Phase I clinical study of safety, tolerability and pharmacokinetic characteristics
主要目的:
评估CZ4D在健康受试者和轻度至中度稳定型哮喘患者中单次及多次给药后的安全性、耐受性,为制定本品的给药方案提供安全的剂量范围。
次要目的:
评估CZ4D在健康受试者和轻度至中度稳定型哮喘患者中单次及多次给药后的药代动力学特征;
评估CZ4D的相对生物利用度。
[Translation] main purpose:
Evaluate the safety and tolerability of CZ4D after single and multiple administrations in healthy subjects and patients with mild to moderate stable asthma to provide a safe dosage range for the formulation of dosing regimens for this product.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of CZ4D after single and multiple doses in healthy subjects and patients with mild to moderate stable asthma;
Assess the relative bioavailability of CZ4D.