臨床研究等提出・公開システム

A randomized, dose escalating, double-blind, placebo-controlled to investigate the safety, tolerability, and efficacy of IRO-203 booster intranasal vaccination in healthy volunteers who have been COVID-19 vaccinated, phase 1 study

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

Tsubaki Atsushi

ID Pharma Co., Ltd.

5F Iidabashi Grand Bloom 2-10-2 Fujimi, Chiyoda-ku, Tokyo

tsubaki-atsushi@iromgp.com

Azuma Aya

ID Pharma Co.,Ltd.

5F Iidabashi Grand Bloom 2-10-2 Fujimi, Chiyoda-ku, Tokyo

+81-3-3264-3131

azuma-aya@iromgp.com

Complete

June. 07, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

-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.

-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.

Both

Prevention of SARS-CoV-2 infection

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.

Safety; adverse events, specific adverse events, laboratory tests, vital signs, 12-lead ECG

Efficacy; serum IgG antibody titer, serum neutralizing antibody titer

+81-3-5213-0028

May. 19, 2023

No

none