Not applicable-healthy volunteer
Conditions
Interventions
Using an administration device (CT-ACB), multiple administration conditions (Pressing load, Amount of explosives) are set and saline is administered intradermally to the upper arm of the study subject
Sponsors
Sakano Seiji
Iga Hiromitsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese* males or females aged 20 years or older and younger than 60 years at the time of informed consent . (*Japanese is defined as having both Japanese parents) 2. Males or females who have given voluntary documentation consent to participate in the study, are in compliance with items of compliance during the study, receive medical examinations specified in the study protocol, and are able to report symptoms etc. 3. Persons who have judged that there are no health problems to participate in the study by the Investigators or sub-investigators.
Exclusion criteria
Exclusion criteria: 1. Subjects with skin diseases such as eczema, dermatitis, and pigment abnormalities at the site where the study device is used. 2. Subjects with injuries or scars at the use site of study device is used. 3. Subjects with sunburn inflammation in the area where study device is used. 4. The investigator or sub-investigator judges that a skin condition or abnormality affecting the evaluation is found at the site where the study device is used, and the administration area using the study device cannot be ensured. 5. Subjects with a history of atopic dermatitis, etc., for whom the principal investigator or the sub-investigator judges it inappropriate to be the subject of the study. 6. Subjects with a history or current medical history of serious cardiovascular, blood, respiratory, hepatic, renal, gastrointestinal system, and neuropsychiatric system. 7. Women who are pregnant, breastfeeding, possibly pregnant, or wish to become pregnant from the time of informed consent to discharge. 8. Subjects who develop skin reactions to disinfectants. 9. Subjects who participated in clinical trials or clinical trials of other unapproved drugs, etc., and received study drugs, etc., within the 28 days prior to the start of this study (the day of administration is the starting day), or who were scheduled to participate in other clinical trials or clinical trials during this study. 10. Other than the above, subject who are judged to be inappropriate as subjects by the principal investigator or the sub--investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Injection volume | — |
Secondary
| Measure | Time frame |
|---|---|
| - Skin properties (hardness, elasticity, viscosity coefficient, viscoelastic modulus, relaxation time, depth) - Wheal diameter - Serious adverse events, diseases, etc. - Defects that may cause serious adverse events | — |
Contacts
Public ContactHiromitsu Iga
Daicel Corporation
Outcome results
None listed