A randomized, double-blind, placebo-parallel controlled clinical study to evaluate the safety and tolerabilityof MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray in healthy subjects

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2022
INTERVENTION: Cohort 1:MY‐586 SARS‐CoV‐2 Neutralizing Antibody Nasal Spray/ placebo;Cohort 2:MY‐586 SARS‐CoV‐2 Neutralizing Antibody Nasal Spray/ placebo;Cohort 3:MY‐586 SARS‐CoV‐2 Neutralizing Antibody Nasal Spray/ placebo; CONDITION: COVID‐19 PRIMARY OUTCOME: Safety evaluation index;Immunotoxicity;Drug concentration; INCLUSION CRITERIA: 1) Subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily participate in the experiment, and sign informed consent before the experiment begins; 2) Healthy subjects aged 18‐65 years (including the threshold) with an appropriate se Xratio between men and women; 3) Body Mass inde X(BMI) = weight (kg)/height 2 (m2), with a BMI in the range of 19.0 to 30.0 (including the cutoff). Male subjects should weigh at least 50.0kg and female subjects should weigh at least 45.0kg 4)The subjects had no birth plan for 3 months from the date of signing the informed consent to the end of the study, and agreed to voluntarily take effective and appropriate contraceptive measures with their partners during this period; 5) COVID‐19 nucleic acid test is negative; 6) Subjects can communicate well with researchers and understand and comply with the requirements of this study. (All above requirements must be
Epistemonikos ID: 0cefef72409e1d4475a48062dd64726a12c89775
First added on: Dec 28, 2022