Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT07124468
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-45 years
* Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
* Pulmonary function at screening:
1. Forced expiratory volume in 1 second (FEV₁) measured/predicted \>80%
2. Forced vital capacity (FVC) measured/predicted \>80%
3. All other ventilation and diffusion parameters normal or with no clinical significance.
* Participant capability:
1. Ability to communicate effectively with investigators
2. Willingness to comply with study procedures
3. Voluntary participation with acceptance of bronchoalveolar lavage (BAL)
4. Provision of written informed consent.
* Reproductive planning:
1. No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose
2. Participant and partner must use protocol-approved contraception.
Exclusion Criteria:
* Hypersensitivity to cephalosporins or carbapenem antibiotics.
* History or current diagnosis of respiratory system diseases.
* History or current diagnosis of coagulation disorders.
* Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems judged by the investigator to interfere with study outcomes.
* History of smoking or positive nicotine test during screening.
* Prior surgery involving pharynx, trachea/bronchi, or lungs.
* Drug abuse history within 1 year prior to screening or positive urine drug screen at screening.
* Alcohol intake \>14 units/week on average within 6 months prior to screening.
* Participation in other clinical trials with investigational drugs/devices within 3 months prior to screening.
* Blood donation/loss ≥400 mL or blood product transfusion within 3 months prior to screening.
* Respiratory infections (bacterial/fungal/viral) within 2 weeks prior to screening (e.g., upper/lower respiratory tract infections).
* Use of any medication/vaccination within 14 days prior to screening or planned vaccination during the study.
* Clinically significant abnormalities in physical examination, 12-lead ECG, or imaging at screening per investigator's judgment.
* Pregnancy, lactation, or positive serum pregnancy test at screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07124468
Study Brief:
Protocol Section:
NCT07124468