A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo

Launched by SAB BIOTHERAPEUTICS, INC. · May 24, 2024

Keywords

ClinConnect Summary

The purpose of this study is to assess the safety of an experimental product for influenza. Influenza, commonly known as the flu, causes substantial illness and death worldwide despite available treatments and vaccines. The U.S. military is susceptible to large outbreaks from new strains of influenza and effective treatment options can be limited. Importantly, the DoD deploys people all over the world. Flu treatment may be more limited overseas. Thus, the military is trying to develop new products to treat and prevent influenza.

The experimental product being testing in this study is calle...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment.
• • 2. Completion and review of assessment of understanding test (achieved \> 70% accuracy).
• • 3. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. Women of childbearing potential: Negative urine pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within two (2) months following investigational product administration.
• • 6. Willing to use an acceptable method of contraception during the study and for 2 months following investigational product administration. If a barrier method is the contraceptive of choice, concurrent use of a spermicide will be recommended.
• • 7. Body mass index (BMI) between 19 and 35 kg/m2. 8. Agree to refrain from blood donation during the study and for at least 12 months (1 year) following injection with the study drug.
• Exclusion Criteria:
• • 1. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other condition that might place the subject at increased risk of adverse events); study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
• • 2. Clinically significant abnormalities on physical examination that, in the PI's opinion, would place the subject at undue risk and/or preclude full evaluation of potential adverse events.
• • 3. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or inherited or acquired immunodeficiency (including IgA deficiency; defined by serum IgA \<7 mg/dL).
• • 4. Women who are pregnant or planning to become pregnant during the study period plus 2 months beyond the last received dose, and currently nursing women.
• • 5. History of buttock enhancement (e.g., silicone enhancement or implants) that may interfere with intramuscular injections.
• • 6. Participation in research involving another investigational product (defined as receipt of an investigational product such as a drug or vaccine or exposure to an invasive investigational device) within 30 days prior to dosing or any time through the last study safety visit.
• • 7. Receipt of any unapproved immunizations or vaccines within 30 days prior to planned dosing.
• • 8. Positive blood test for HBsAg, HCV, or HIV-1/2. 9. Clinically significant abnormalities on basic laboratory screening. 10. Moderate or severe influenza requiring hospitalization in the 30 days prior to planned dosing.
• • 11. Receipt of any blood product (e.g., RhoGam, IVIG) within 120 days prior to planned dosing.
• • 12. Use of other drugs that, in the opinion of the investigator, could complicate the safety assessment of SAB-176 (e.g., medications or over-the-counter vitamins or supplements formulated in bovine gelatin).
• • 13. Vaccination against influenza less than 90 days prior to product administration.
• • 14. Known autoimmune condition requiring therapy more intensive than intermittent nonsteroidal anti-inflammatories in the 6 months prior to planned dosing (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease).
• • 15. Chronic respiratory disease including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen.
• • 16. Chronic asthma requiring the use of oral steroids or hospitalization in the last six months; inhaled steroids are permitted.
• • 17. Receipt of pooled immunoglobulin or plasma within 30 days prior to planned dosing.
• • 18. History of allergy, anaphylaxis, or severe reaction to beef products (including dairy products and gelatin).

Trial Officials