Prevention of SARS-CoV-2 infection
Conditions
Interventions
IRO-203, high dose, medium dose, low dose, or placebo will be nebulized into each nostril at 0.25 mL for a total of 0.5 mL using a intranasal spray device.
Sponsors
Tsubaki Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects aged over 18 at the time of obtaining informed consent. -Subjects who can comply with the requirements and restrictions described in this protocol, visit the hospital at the prescribed time, and undergo necessary tests, etc. -Subjects who have received two or more other new coronavirus vaccines in the past, and three months or more have passed since the most recent vaccination. -Subjects who agree not to donate blood during the clinical study period. -If the female subject or the male subject's partner is possibility pregnancy, who can consent to use medically effective contraception during the clinical study.
Exclusion criteria
Exclusion criteria: -Subjects who have SARS-CoV-2 PCR test positive for SARS-CoV-2. -Subjects who have been infected with SARS-CoV-2 in the past or suspected of being infected. -Subjects with symptoms suspected of being infected with SARS-CoV-2. -Subjects suffering from severe acute diseases. -Current history of cardiovascular, including thrombosis, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disease, and the investigator decides the subject has a safety issue. -Subjects with a history of convulsions due to vaccination or epilepsy. -Subjects with current or past history of myocarditis or pericarditis. -Subjects who have thrombocytopenia, coagulopathy, and those undergoing anticoagulant therapy. -Subjects who have a fever of 37.5 degrees Celsius or higher on the day of administration of the investigational product. -Subjects who have received immunosuppressive treatment within 6 months before vaccination with this investigational product. -Subjects who have received other investigational products within 3 months before vaccination with this investigational product. -Female subjects who are pregnant, wish to become pregnant during the clinical study, or have indicated that they are breast-feeding, or have a positive pregnancy test at the time of screening. -Subjects who have drug allergies, including allergies to vaccines, or other allergies that are considered inappropriate for study participation in the opinion of the investigators. -Subjects who are positive for HIV, HBV, HCV antibody or syphilis test. -Subjects who have olfactory abnormalities as a result of the olfactory test performed before vaccination with the study drug and an examination by an otolaryngologist. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; adverse events, specific adverse events, laboratory tests, vital signs, 12-lead ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; serum IgG antibody titer, serum neutralizing antibody titer | — |
Contacts
Public ContactAya Azuma
ID Pharma Co.,Ltd.
Outcome results
None listed