Randomized, double-blind and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of SYH2059 powder for inhalation after single and multiple doses in healthy subjects. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2059 powder for inhalation. Part 2 is to assess the safety, tolerability and pharmacokinetics of a multiple ascending dose of SYH2059 powder for inhalation.
1) Adults aged 18 ~ 55 years (inclusive), male or female;
2) Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m² (inclusive);
3) Participant has not engaged in unprotected sexual intercourse within 14 days before screening, and participant and their partner agree to use effective non-hormonal contraception (such as condoms, inert intrauterine devices, female barrier method (cervical cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.) from signing the ICF to 6 months after the end of the study; No sperm donation plan for male participants from signing the ICF to 6 months after the end of the study, and no egg donation plan for female participants from signing the ICF to 6 months after the end of the study;
4) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written ICF and can comply with the trial procedures.
1) History of neurological/psychiatric system, respiratory, endocrine, hematological, musculoskeletal, gastrointestinal, and cardiovascular diseases; hepatic and renal diseases, thymic disorders or other diseases that may affect the study results;
2) History of severe drug and food allergies, including allergy to the product or its components; history of herpes zoster infection;
3) Pulmonary ventilation function test showing FEV1 measured value/predicted FEV1 ≤ 80% or FVC ≤ 80% of predicted value, or clinically significant;
4) History of COPD or other respiratory diseases, such as active or inactive tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, overt asthma, positive bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease;
Parallel
SYH2059
DrugInhalation administration
Placebo
DrugInhalation administration
The Number of adverse events (AEs)
Area under the concentration-time curve (AUC)
Plasma Maximum concentration (Cmax)
Half-Life (t1/2)
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
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