Created at Source Raw Value Validated value
June 25, 2024, noon usa

* abnormal nasal or throat exam at enrollment * if female, pregnancy, or within 42 days of last pregnancy at screening * if female, breastfeeding * diagnosed with sars-cov-2 in the past 42 days at screening * diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic sars-cov-2) * participation in an investigational drug study in past 30 days at screening * any condition that, in the opinion of the investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives * use of any intranasal product in the 14 days prior to enrollment * surgical procedure involving the nose or throat 90 days prior to enrollment * any of the following laboratory abnormalities at screening: 1. hgb \< 12g/dl (men) and \< 11g/dl (women) 2. serum creatinine \> 1.1 x upper limit of normal 3. alanine transaminase, aspartate aminotransferase, and total bilirubin \> 1.1 x upper limit of normal * grade 2 or higher seasonal allergies at the time of enrollment * reported use of illicit drugs 1. non-therapeutic injection drug use in the 12 months prior to screening 2. any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening * use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment

* abnormal nasal or throat exam at enrollment * if female, pregnancy, or within 42 days of last pregnancy at screening * if female, breastfeeding * diagnosed with sars-cov-2 in the past 42 days at screening * diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic sars-cov-2) * participation in an investigational drug study in past 30 days at screening * any condition that, in the opinion of the investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives * use of any intranasal product in the 14 days prior to enrollment * surgical procedure involving the nose or throat 90 days prior to enrollment * any of the following laboratory abnormalities at screening: 1. hgb \< 12g/dl (men) and \< 11g/dl (women) 2. serum creatinine \> 1.1 x upper limit of normal 3. alanine transaminase, aspartate aminotransferase, and total bilirubin \> 1.1 x upper limit of normal * grade 2 or higher seasonal allergies at the time of enrollment * reported use of illicit drugs 1. non-therapeutic injection drug use in the 12 months prior to screening 2. any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening * use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment

Jan. 8, 2022, 8 a.m. usa

abnormal nasal or throat exam at enrollment if female, pregnancy, or within 42 days of last pregnancy at screening if female, breastfeeding diagnosed with sars-cov-2 in the past 42 days at screening diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic sars-cov-2) participation in an investigational drug study in past 30 days at screening any condition that, in the opinion of the investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives use of any intranasal product in the 14 days prior to enrollment surgical procedure involving the nose or throat 90 days prior to enrollment any of the following laboratory abnormalities at screening: hgb < 12g/dl (men) and < 11g/dl (women) serum creatinine > 1.1 x upper limit of normal alanine transaminase, aspartate aminotransferase, and total bilirubin > 1.1 x upper limit of normal grade 2 or higher seasonal allergies at the time of enrollment reported use of illicit drugs non-therapeutic injection drug use in the 12 months prior to screening any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment

abnormal nasal or throat exam at enrollment if female, pregnancy, or within 42 days of last pregnancy at screening if female, breastfeeding diagnosed with sars-cov-2 in the past 42 days at screening diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic sars-cov-2) participation in an investigational drug study in past 30 days at screening any condition that, in the opinion of the investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives use of any intranasal product in the 14 days prior to enrollment surgical procedure involving the nose or throat 90 days prior to enrollment any of the following laboratory abnormalities at screening: hgb < 12g/dl (men) and < 11g/dl (women) serum creatinine > 1.1 x upper limit of normal alanine transaminase, aspartate aminotransferase, and total bilirubin > 1.1 x upper limit of normal grade 2 or higher seasonal allergies at the time of enrollment reported use of illicit drugs non-therapeutic injection drug use in the 12 months prior to screening any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment