A study of the changes of biomarkers for A-803 in healthy adult male smokers

A study of the changes of biomarkers for A-803 in healthy adult male smokers - A biomarker study for A-803

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004334

Enrollment

Registered

2011-12-31

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokers, nonsmokers

Interventions

&lt

Smokers&gt

Use of subject&#39

s usual cigarette brand (for two days) =&gt

Use of A-803 (for twenty-eight days) &lt

Use of a conventional tobacco product (for twenty-eight days) &lt

Nonsmokers&gt

No tobacco product use

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Subjects who sign the study-specific consent form 2. Subjects who are confirmed to be in good health through the screening process 3. For smokers, subjects who do not plan to quit smoking over the study period 4. For nonsmokers, subjects who do not plan to use tobacco products over the study period etc.

Exclusion criteria

Exclusion criteria: 1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco 2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation) etc.

Design outcomes

Primary

Measure	Time frame
To investigate the change of biomarkers of effect in healthy adult male smokers during four-week use of A-803 in comparison with a conventional tobacco product	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026