Intranasal booster of IRO-203 to people had new corona virus vaccines, phase 1 study.

JRCT ID: jRCT2031230116

Registered date:07/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of SARS-CoV-2 infection
• Date of first enrollment: 07/06/2023
• Target sample size: 84
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Safety; adverse events, specific adverse events, laboratory tests, vital signs, 12-lead ECG
• Secondary Outcome: Efficacy; serum IgG antibody titer, serum neutralizing antibody titer

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tsubaki Atsushi