This is a cross-sectional 3-group study with subjects enrolled and matched by region (Asia, Europe), age, sex, and average daily product consumption over the last 2 years as self-reported. The study will be conducted as a multi-center and multi-regional study.
Who can participate
Age range
30 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is able to understand the information provided in the main ICF and has signed the main ICF.
* Subject is 30-60 years old.
* Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
Cigarette smokers:
* Has smoked ≥ 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening.
* Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 10 years.
* Has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past 2 years prior to screening.
* Smoking status will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (≥ 10 ppm (1)).
THS users:
* Has used ≥ 10 HeatSticks/day on average over the past 2 years prior to screening.
* Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to switching to THS.
* Has smoked \< 30 cigarettes/month and used other tobacco products or e-cigarettes \< daily over the past 2 years prior to screening.
* Product use will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (\< 10 ppm).
Former cigarette smokers:
* Has not smoked cigarettes or used any tobacco or nicotine-containing products on a daily basis over the past 2 years prior to screening.
* Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to stopping smoking.
* Smoking status will be ve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Carboxyhemoglobin (COHb) in Blood
Timeframe: Measured when subject visits study site on day 1.
2
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine
Timeframe: Measured when subject visits study site on day 1.
3
White Blood Cell Total Count (WBC) in Blood
Timeframe: Measured when subject visits study site on day 1.
4
8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine
Timeframe: Measured when subject visits study site on day 1.