Created at Source Raw Value Validated value
March 25, 2021, 12:31 a.m. usa

None

None

Nov. 19, 2020, 12:31 a.m. usa

- known hypersensitivity to any constituent of the investigational medicinal product. - hepatitis b infection indicated by detectable hbsag (hepatitis b surface antigen) in blood. - detectable antibodies against hepatitis c virus in blood unless active hepatitis c is ruled out by negative hcv-rna. - hiv infection indicated by detectable hiv antigen and/or hiv antibodies in blood. - blood laboratory parameter abnormalities as listed below - neutrophil count ≤1,000 cells/µl - hemoglobin ≤10 g/dl - platelet count ≤100,000 cells/µl - alt ≥2.0 x uln - ast ≥2.0 x uln - total bilirubin ≥1.5 uln - egfr <60 ml/min/1.73m2 - pregnancy or lactation. - any vaccination within 14 days prior to dzif-10c administration. - receipt of any sars-cov-2 vaccine or sars-cov-2 monoclonal antibody in the past. - diagnosis of bronchial asthma or history of bronchial hyperresponsiveness. - any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. - history of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable). - participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study. - any kind of dependency on the principal investigator or employment by the sponsor or principal investigator - legally incapacitated individuals - individuals held in an institution by legal or official order - if engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception

- known hypersensitivity to any constituent of the investigational medicinal product. - hepatitis b infection indicated by detectable hbsag (hepatitis b surface antigen) in blood. - detectable antibodies against hepatitis c virus in blood unless active hepatitis c is ruled out by negative hcv-rna. - hiv infection indicated by detectable hiv antigen and/or hiv antibodies in blood. - blood laboratory parameter abnormalities as listed below - neutrophil count ≤1,000 cells/µl - hemoglobin ≤10 g/dl - platelet count ≤100,000 cells/µl - alt ≥2.0 x uln - ast ≥2.0 x uln - total bilirubin ≥1.5 uln - egfr <60 ml/min/1.73m2 - pregnancy or lactation. - any vaccination within 14 days prior to dzif-10c administration. - receipt of any sars-cov-2 vaccine or sars-cov-2 monoclonal antibody in the past. - diagnosis of bronchial asthma or history of bronchial hyperresponsiveness. - any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. - history of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable). - participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study. - any kind of dependency on the principal investigator or employment by the sponsor or principal investigator - legally incapacitated individuals - individuals held in an institution by legal or official order - if engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception