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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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. This is a Phase 1, randomized, double-blind, placebo-controlled clinical trial in which a total of 28 subjects will receive an injection of either SAB-176 or placebo (normal saline). The investigational product will be administered intramuscularly (IM) on Day 1. Four dose escalation cohorts of 7 subjects (5 active and 2 placebo) each are planned. Subjects will be randomized to receive either SAB-176 or placebo in a double-blinded manner. Progression to subsequent dose-escalating cohorts will be dependent on safety measured through Day 5 after dosing of the previous cohort. Blood specimens will be collected at prescribed intervals to examine pharmacokinetics and immunogenicity. Safety will be actively monitored during investigational product administration and for 60 days following dosing. The decision to advance to the next cohort will be based solely on the safety assessment through Day 5. All safety data will be summarized and reviewed by the PI, the Sponsor's Clinical Monitor, and the Research Monitor prior to next cohort dose-escalation.

Research Team

Nehkonti Adams, MD

Principal Investigator

Naval Medical Research Command (NMRC)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+