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

NCT04471038 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: SAB-176-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza Type A; Influenza Type B; Influenza

Outcome Measures

Primary Outcomes (1)

• Number of Participants Having Adverse Events

  Incidence and severity of other adverse events and severe adverse events (SAE)

  90 days

Secondary Outcomes (1)

• Number of Participants With Anti-SAB-176 Antibodies Elicited by SAB-176

  90 Days

Study Arms (5)

Cohort 1

EXPERIMENTAL

1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)

Biological: SAB-176

Cohort 2

EXPERIMENTAL

10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)

Biological: SAB-176

Cohort 3

EXPERIMENTAL

25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)

Biological: SAB-176

Cohort 4

EXPERIMENTAL

50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)

Biological: SAB-176

Cohort 5

PLACEBO COMPARATOR

Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Other: Normal Saline

Interventions

SAB-176 BIOLOGICAL

Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Normal Saline OTHER

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

Cohort 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years and ≤60 years
• Body mass index (BMI) of 19-32 kg/m2
• 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.
• Estimated glomerular filtration rate ≥90 mL/min at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• 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.

You may not qualify if:

• Any history of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)
• Any history of allergy, anaphylaxis, or severe reaction to IVIg or human blood products
• 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.
• History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained syncope
• Abnormal clinically significant 12-lead electrocardiogram (ECG), per PI discretion
• 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.
• Enrollment will be delayed for all patients who have other intercurrent infections (e.g., gastroenteritis, abscess, etc.).
• Women who are breast-feeding
• Positive urine or serum pregnancy test
• Positive urine drug screen (UDS)
• Clinically significant results, including laboratory results, as determined by study investigator
• Positive rheumatoid factor
• IgA deficiency (defined as IgA less than 7 mg/dL)
• 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
• Participation in any other research study until the completion of the study

Sponsors & Collaborators

• SAb Biotherapeutics, Inc.: lead

Study Sites (1)

PPD, Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Director Clinical Operations
• Organization: SAB Biotherapeutics

ssinclair@sab.bio

8326221699

Study Officials

• Rebecca N Wood-Horrall, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, placebo-controlled dose-escalating cohort design

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 14, 2020
• Study Start: July 29, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication and ending 36 months following article publication
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)