SAB-176 for Flu

(SAB-176-103 Trial)

Overseen By Angela Phillips, RN, BSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: SAb Biotherapeutics, Inc.

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Diabetes, Hypertension, Autoimmune, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new flu treatment called SAB-176 to determine its safety and tolerability when administered as a shot. It is designed to help prevent the flu before or after exposure. The trial tests different doses of SAB-176 to establish a safe range. Participants should be healthy adults who haven't recently experienced severe flu and do not have chronic asthma requiring oral steroids. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those using immunosuppressive drugs or other medications that could complicate the safety assessment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SAB-176 is likely to be safe for humans?

Research has shown that SAB-176 is safe and well-tolerated in healthy individuals. Earlier studies reported no major health changes from the start. The most common side effect was mild and temporary. These findings suggest that SAB-176 might be safe for use. However, as this is an early-stage trial, further research is necessary to confirm its safety for all. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for flu?

Researchers are excited about SAB-176 for flu because it represents a fresh approach to fighting the virus. Unlike traditional treatments like antivirals, which often target viral replication, SAB-176 is a polyclonal antibody treatment that targets multiple components of the flu virus, potentially offering broader and more robust protection. This could mean faster-acting relief and effectiveness against a wider range of flu strains. Additionally, SAB-176's antibody-based mechanism might enhance its ability to prevent the flu from taking hold, offering a promising new tool in our fight against this common and often debilitating illness.

What evidence suggests that SAB-176 might be an effective treatment for flu?

Research has shown that SAB-176, which participants in this trial may receive, provides broad protection against various flu virus strains. This treatment employs a new method involving human antibodies, proteins that help the body fight infections. These antibodies aim to stop the flu virus, potentially preventing illness. Early studies found that SAB-176 is safe and well-tolerated in healthy people. Although still in early testing, its promising approach suggests it might effectively prevent the flu. ^{1 2 4 5 6}

Who Is on the Research Team?

Nehkonti Adams, MD

Principal Investigator

Naval Medical Research Command (NMRC)

Are You a Good Fit for This Trial?

Healthy adults who can receive an intramuscular injection are eligible for this trial. The study is not suitable for individuals with certain health conditions, but specific exclusion criteria are not listed.

Inclusion Criteria

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

Completion and review of assessment of understanding test (achieved > 70% accuracy)

I agree not to donate blood during and for a year after the study.

Exclusion Criteria

I haven't received any blood products in the last 4 months.

I have not received any immunoglobulin or plasma treatments in the last 30 days.

I am not taking any medications or supplements that could interfere with the trial drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an intramuscular injection of SAB-176 or placebo on Day 1. Safety and pharmacokinetics are assessed.

1 day

1 visit (in-person)

Safety Monitoring

Participants are monitored for safety and adverse events for 60 days post-injection.

60 days

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SAB-176

Trial Overview The trial is testing SAB-176, a potential flu prevention treatment given by injection, against a placebo (saline solution). It's in Phase 1 with dose escalation to ensure safety before increasing the amount given to participants.

How Is the Trial Designed?

Group I: SAB-176 5mL Experimental Treatment 1 Intervention

5 mL (\~375 mg) SAB-176 dose

Group II: SAB-176 3mL Experimental Treatment 1 Intervention

3 mL (\~225 mg) SAB-176 dose

Group III: SAB-176 20mL Experimental Treatment 1 Intervention

20 mL (\~1500 mg) SAB-176 dose

Group IV: SAB-176 1 mL Experimental Treatment 1 Intervention

1 mL (\~75 mg) SAB-176 dose

Group V: Placebo 1mL Placebo Group 1 Intervention

Normal Saline

Group VI: Placebo 20mL Placebo Group 1 Intervention

Normal Saline

Group VII: Placebo 3mL Placebo Group 1 Intervention

Normal Saline

Group VIII: Placebo 5mL Placebo Group 1 Intervention

Normal Saline

Who Is Running the Clinical Trial?

SAb Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

4,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06435936?cond=(PSEUDOHYPOALDOSTERONISM,%20TYPE%20I,%20AUTOSOMAL%20DOMINANT)%20OR%20(NR3C2)&rank=2

A Study to Assess the Safety of SAB-176 to Prevent the Flu, ... This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post prophylactic for influenza.

2. ir.sab.bio ir.sab.bio/static-files/ada5283c-db0e-45d5-8857-4999a1d1fd5a

Safety and Efficacy Results from Phase 1 and ... SAB-176 was safe and well tolerated by the healthy subjects. No clinically meaningful changes from baseline were observed. The most commonly reported TEAE was ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04850898

Study of SAB-176 in Healthy Adult Participants Lower scores represent a better outcome. Peak symptom diary card score: peak total clinical symptoms (TSS) as measured by graded symptom scoring system to ...

4. ir.sab.bio ir.sab.bio/news-releases/news-release-details/sab-biotherapeutics-granted-fast-track-designation-fda-sab-176

Release Details - Investor Relations | SAB Biotherapeutics The data indicate that SAB-176 offers broad antibody protection against multiple strains of this rapidly mutating virus. In the Phase 2a study, ...

5. nature.com nature.com/articles/d43747-023-00050-y

Novel biologic modality proven to maintain its efficacy ... SAB Biotherapeutics has tested its hIgG therapeutic, SAB-185, which was shown to be effective against tested strains, from Delta to Omicron, including some ...

6. withpower.com withpower.com/trial/phase-1-pha1a-3-2024-0b649

SAB-176 for Flu · Info for Participants This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post prophylactic for influenza.