Healthy male/female adults
Conditions
Interventions
Inhalation of aerosolized hypochlorous acid solution to the subject, for 28 days.
Inhalation of aerosolized tap-water to the subject, for 28 days.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects who are not less than 20 years old at informed consent. (2) Subjects who can inhale the aerosolized test agent in their non-ventilating private room which is not bigger than 25.54 m2, for 8-10 hours a day during this trial. (3) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who take steadily in some kind of medicine continuously. (2) All throughThroughout this trial, subjects who have any difficulty in refraining from inhaling the other antiseptic aerosols, which might affect the test results. (3) Pregnant, possibly pregnant, or lactating women. (4) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Subjects falling intowho have the habit of excessive alcohol intake. (6) Subjects with extremely irregular eating habit, and/or irregular life rhythm including an irregular shift work or a midnight one. (7) Subjects with drug and/or chemical allergy. (8) Subjects who are now under the other clinical tests with some kind of medicine and/or health food, or took part in those within 28 days before this trial, or are planning to participate in those after giving informed consent to take part in this trial. (9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (10) Males who donated their whole blood (400 mL) within the last three months to this trial. (11) Females who donated their whole blood (400 mL) within the last four months to this trial. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Others who have been determined as ineligible for participation in this trial, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, and incidence rate of side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Questionnaire about physical condition 2. Physical measurement 3. Physiological test 4. Hematologic test 5. Blood-biochemical test 6. General urinalysis | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Fujimoto
CPCC Company Limited Clinical Planning Department
Outcome results
None listed