Influenza Type APhase 1NCT04471038
Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants
A Phase 1 study testing SAB-176 and Normal Saline in people with Influenza Type A and Influenza Type B, run by SAb Biotherapeutics, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Type A, Influenza Type B, Influenza
- What is being tested?
- SAB-176 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 19 Apr 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Receipt of blood products within 2 months prior to study drug administration (i.e.Day 0)
- Receipt of any vaccination within 30 days prior to study drug administration (i.e.Day 0)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults
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.
Read the detailed description
This safety and tolerability study of IV SAB-176 consisted of up to 4 single dose levels or cohorts (Cohort 1 through 4) in a double-blind, randomized, placebo-controlled dose-escalating cohort design. Four cohorts of 3 to10 subjects each were administered a single IV dose of SAB-176 or saline placebo. At very low doses, the concern was primarily allergic or T-cell activation/cytokine storm, so small cohort sizes were utilized. As the target dose was approached, the sample size was increased to increase the likelihood of detecting toxicity events.
- Conditions
- Influenza Type A, Influenza Type B, Influenza
- Being tested
- SAB-176, Normal Saline
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAB-176Biological
Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
Normal SalineOther
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%) Receives: Biological: SAB-176 |
| Cohort 2 | Experimental | 10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%) Receives: Biological: SAB-176 |
| Cohort 3 | Experimental | 25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) Receives: Biological: SAB-176 |
| Cohort 4 | Experimental | 50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) Receives: Biological: SAB-176 |
| Cohort 5 | Placebo comparator | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Having Adverse Events
Incidence and severity of other adverse events and severe adverse events (SAE)
Measured: 90 days
Secondary outcomes (1)
Number of Participants With Anti-SAB-176 Antibodies Elicited by SAB-176
Number of subjects showing antidrug antibodies to SAB-176 through day 90
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start29 Jul 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza Type AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- double-blind, randomized, placebo-controlled dose-escalating cohort design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAb Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca N Wood-Horrall, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471038
- Sponsor's protocol ID
- SAB-176-101
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2020
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04471038
- Acronym / sponsor ID
- SAB-176-101
- Conditions
- Influenza Type A, Influenza Type B, Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- SAb Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This safety and tolerability study of IV SAB-176 consisted of up to 4 single dose levels or cohorts (Cohort 1 through 4) in a double-blind, randomized, placebo-controlled dose-escalating cohort design. Four cohorts of 3 to10 subjects each were administered a single IV dose of SAB-176 or saline placebo. At very low doses, the concern was primarily allergic or T-cell activation/cytokine storm, so small cohort sizes were utilized. As the target dose was approached, the sample size was increased to increase the likelihood of detecting toxicity events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- double-blind, randomized, placebo-controlled dose-escalating cohort design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: SAB-1761 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%) |
| Cohort 2 | Experimental | Biological: SAB-17610 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%) |
| Cohort 3 | Experimental | Biological: SAB-17625 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) |
| Cohort 4 | Experimental | Biological: SAB-17650 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) |
| Cohort 5 | Placebo comparator | Other: Normal SalineNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAB-176Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived) | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Normal SalineNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm | Other | Cohort 5 |
Primary outcome
Number of Participants Having Adverse Events
Time frame: 90 days
Incidence and severity of other adverse events and severe adverse events (SAE)
1 secondary outcome
Number of Participants With Anti-SAB-176 Antibodies Elicited by SAB-176
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca N Wood-Horrall, MD principal investigator
PPD Development, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAB-176 and Normal Saline in people with Influenza Type A and Influenza Type B, run by SAb Biotherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Having Adverse Events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.