This is a Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820, a Monoclonal Antibody Cocktail Being Tested for the Treatment and Prevention of COVID-19
This is a Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820, a Monoclonal Antibody Cocktail Being Tested for the Treatment and Prevention of COVID-19
ADM03820 is indicated for the treatment and prevention of SARS-CoV-2 (COVID-19) in adults.
 The primary purpose of this study is to assess the safety of ADM03820 in healthy male and
 female subjects compared to placebo.
Inclusion Criteria:

 1. Informed consent understood and signed

 2. Healthy male or healthy, non-pregnant, non-lactating female

 3. Willingness to comply and be available for all protocol procedures for the duration of
 the study

 4. Between the ages of 18 and 55, inclusive on the day of dosing

 5. Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2

 6. Female subjects of childbearing potential must have a negative serum pregnancy test at
 screening and negative urine pregnancy test on Day 1 prior to dosing.

 -  Note: A woman is considered of childbearing potential unless post-menopausal (>
 or = 1 year without menses without other known or suspected cause and
 appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy
 or hysterectomy

 7. Females of childbearing potential and males agree to use acceptable contraception for
 the duration of the study

 -  Note: These include progestin implants, intrauterine devices (IUDs), surgical
 (hysterectomy or tubal ligation; vasectomy) or abstinence. Use of methods such as
 progestin injectables, combined oral hormonal contraceptives, condoms, and
 diaphragms will not be acceptable when used alone, but they could be considered,
 if used in combination with another method (for example, a female using combined
 oral contraceptives if her male partner is sterile, or if she and her non-sterile
 male partner use a double-barrier method), after consultation with the Ology
 Bioservices MM. All males will be required to use a barrier method (condoms) for
 the duration of the study

 8. Screening laboratory tests are within normal ranges or outside the normal ranges and
 considered not clinically significant by the Principal Investigator

 1. If urinalysis by dipstick is abnormal, a complete urinalysis with microscopic
 evaluation will be performed and the results will supersede the results of the
 dipstick for blood, glucose, and protein.

 2. Menstruating females failing inclusion criteria due to a positive blood on urine
 test may be retested following cessation of menses.

 3. Other laboratory values that are outside the range of eligibility but are thought
 to be due to an acute condition or collection or laboratory error may be repeated
 once.

 9. The urine drug screen is negative

 10. Breathalyzer test is negative and subject agrees to abstain from alcohol consumption
 for a period of 2 days prior to dosing and 2 days prior to any study visit.

 11. Agree to minimize risk of SARS-CoV-2 infection.

 Exclusion Criteria:

 1. History of chronic medical condition that would either interfere with the accurate
 assessment of the objectives of the study or increase the risk profile of the subject.

 2. Subjects with cardiovascular disease

 3. Subjects with diabetes

 4. Subjects with pulmonary diseases such as COPD or asthma

 5. History of severe allergic reactions of any type to medications, bee stings, food, or
 environmental factors or hypersensitivity or reaction to immunoglobins.

 6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
 QTc interval >450 milliseconds)

 7. Clinically significant abnormal electrocardiogram at screening.

 -  Note: Clinically significant abnormal ECG results include but not limited to:

 complete left or right bundle branch block; other ventricular conduction block; 2nd
 degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia;
 sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern
 of ST elevation felt consistent with cardiac ischemia; or any condition deemed
 clinically significant by a study investigator

 -  Incomplete right bundle branch block is not exclusionary if there are no abnormal
 ECG findings and there is no clinical history or evidence on physical examination
 to indicate cardiac disease.

 8. Positive serology results for HIV, HBsAg, or HCV antibodies

 9. Febrile illness with temperature ≥38°C within 7 days of dosing

 10. Female subject who is pregnant or breastfeeding

 11. Donated blood within 56 days of enrollment

 12. Known allergic reactions to any of the study product components present in the
 formulation or in the processing, as listed in the Investigator Brochure

 13. Treatment with another investigational drug within 28 days of dosing

 14. Treatment with a monoclonal antibody within 3 months of enrollment

 15. Positive serology results for SARS-CoV-2 antibodies.

 16. Positive results from a reverse transcriptase polymerase chain reaction (RT PCR) test
 for SARS CoV 2

 17. Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion
 within 6 months or within 5 half-lives of the specific product given

 18. Active drug or alcohol use disorder or dependence that, in the opinion of the
 investigator, would interfere with adherence to study requirements

 19. Use of H1 antihistamines or beta-blockers within 5 days of dosing

 20. Use of any prohibited medication within 28 days prior to screening or planned use
 during the study period

 -  Note: Prohibited medications include immunosuppressives (except Nonsteroidal
 Anti-Inflammatory Drugs [NSAIDS]); immune modulators; oral corticosteroids
 (topical/intranasal steroids are acceptable); anti-neoplastic agents

 21. Any specific condition that in the judgment of the investigator precludes
 participation because it could affect subject safety

 22. Plans to enroll or is already enrolled in another clinical trial that could interfere
 with safety assessment of the investigational product at any time during the study
 period

 -  Note: Includes trials that have a study intervention such as a drug, biologic, or
 device

 23. Is a study site employee or staff

 -  Note: Site employees or staff include the PIs and sub-investigators or staff who
 are supervised by the PI or Sub-Investigators