Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants

Influenza Clinical Trial

Official title:

A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04471038
• Other study ID #: SAB-176-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 29, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2021
• Source: SAb Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Influenza causes substantial morbidity and mortality worldwide despite available antivirals and vaccines. SAB Biotherapeutics, Inc. has developed SAB-176, an anti-influenza human immunoglobulin (transchromosomic [Tc] bovine-derived) intravenous therapeutic to treat past and current strains of Type A Influenza and Type B Influenza. This study will evaluate the safety, tolerability, and pharmacokinetics of SAB-176 in healthy participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: December 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age =18 years and =60 years

2. Body mass index (BMI) of 19-32 kg/m2

3. Subjects must have values in normal ranges for basic labs (i.e., CBC, PT/INR, Chem-7, and LFTs), unless deemed not clinically significant by the PI.

4. Estimated glomerular filtration rate =90 mL/min at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

5. Subjects must agree to:

Not take any prescription or over-the-counter (OTC) medications with the exception of acetaminophen, ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive medications, or others unless approved by the study investigator, for a period 7 days prior to study drug administration (i.e., Day 0). Use one of the following in order to avoid pregnancy: Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of the subject's signing of the informed consent form through 60 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method.

Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject's signing of the informed consent form through 60 days after the last dose of study drug.

Neither females or males should donate oocysts or sperm for use in artificial insemination through 60 days after the last dose of study drug.

Exclusion Criteria:

1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)

2. Any history of allergy, anaphylaxis, or severe reaction to IVIg or human blood products

3. Any chronic medical problem/condition that require medications needed to maintain the subject's health. Exceptions to this restriction can be allowed for minor health conditions that are treated with Tylenol, over-the-counter non-steroidal anti-inflammatories, vitamins, seasonal allergy medications, or oral/transdermal/IUD contraceptives, etc. The study investigator will make a determination to exclude a subject based upon their medical history and the type and frequency of the drug substance.

4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope

5. Abnormal clinically significant 12-lead electrocardiogram (ECG), per PI discretion

6. Subjects who have been laboratory confirmed or clinically diagnosed with influenza within seven days prior to infusion (by subject history) will be deferred from infusion. Any subject with signs and symptoms of an active respiratory infection on the day of infusion will be deferred until the infection is cleared in the opinion of the investigator. Subjects that present with an active upper respiratory infection on the day of infusion will be tested with an FDA licensed Influenza A/B Antigen Test. Signs and symptoms constituting an upper respiratory infection include cough, sore throat, or rhinorrhea with or without fever.

7. Enrollment will be delayed for all patients who have other intercurrent infections (e.g., gastroenteritis, abscess, etc.).

8. Women who are breast-feeding

9. Positive urine or serum pregnancy test

10. Positive urine drug screen (UDS)

11. Clinically significant results, including laboratory results, as determined by study investigator

12. Positive rheumatoid factor

13. IgA deficiency (defined as IgA less than 7 mg/dL)

14. Participation in another research study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0) and until completion of the study

15. Participation in any other research study until the completion of the study

16. Receipt of blood products within 2 months prior to study drug administration (i.e.Day 0)

17. Receipt of any vaccination within 30 days prior to study drug administration (i.e.Day 0)

18. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

Related Conditions & MeSH terms

• Influenza
• Influenza Type A
• Influenza Type B
• Influenza, Human

Intervention

Biological:
• SAB-176
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Other:
• Normal Saline
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm

Locations

Country	Name	City	State
United States	PPD, Phase 1 Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SAb Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants having adverse events	Incidence and severity of other adverse events and severe adverse events (SAE)	90 days
Secondary	Measurement of Serum SAB-176 Titers	Measurement of Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90	90 Days
Secondary	Assessment of the PD of SAB-176 administered Intravenously	Influenza antibody titers in serum using hemagglutination Inhibition (HAI) assay screening through Study Day 90	90 Days
Secondary	Ability of serum SAB-176 levels to neutralize Influenza to day 90	Serum levels of SAB-176 using microneutralization (MN) assay through day 90	90 Days
Secondary	Immune response elicited by SAB-176	Measurement of rheumatoid factor through day 90	90 Days
Secondary	Concentration of subject anti-SAB-176 antibodies elicited by SAB-176	Measurement of anti-SAB-176 antibodies through day 90	90 Days