Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19

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 or blood/saliva alcohol 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 (Not applicable for Cohort 5).

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

24. Received an approved COVID-19 vaccine (subjects can receive an approved COVID-19
vaccine after completing their Day 90 visit). For Cohort 5, subjects who received a
COVID-19 vaccine within 14 days prior to enrollment are excluded.