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:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05789420
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed the ICF and is able to understand the information provided in the ICF.
* Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last \> 6 months in total).
* Subject has continuously smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
* Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).
* Subject does not plan to quit smoking within the next three months.
Exclusion Criteria:
* As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
* Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
* Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
* Subject experienced within 30 days prior to screening/admission a body temperature \>37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) or the subject has a confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment)
* As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
* Subject has relevant history of, or current asthma condition or COPD condition, and/or clinically significant findings.
* Subject has donated blood or received whole blood or blood products within 3 months.
* BMI \< 18.5 kg/m2 or ≥ 32.0 kg/m2.
* Positive serology test for HIV 1/2, HBV, or HCV.
* Subject has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
* The subject has a positive urine drug test.
* Subject or one of their family members is a current or former employee of the tobacco or e-cigarette industry.
* Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
* Subject has participated in another clinical study within 3 months.
* Subject has been previously screened or enrolled in this study.
* Subject is pregnant (does not have negative pregnancy tests at Screening and at Baseline) or is breastfeeding.
* For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05789420
Study Brief:
Protocol Section:
NCT05789420