A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo

NCT06435936 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SAB-176-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PHA1A

Outcome Measures

Primary Outcomes (3)

• Occurrence of solicited local and systemic adverse events (AEs) through Day 29.

  Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.

  Dosing through Day 29

• Occurrence of IP-related unsolicited AEs through Day 61.

  Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.

  Dosing through Day 61

• Occurrence of serious adverse events (SAEs) through Day 61.

  Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.

  Dosing through Day 61

Secondary Outcomes (9)

• Hemagglutination Inhibition (HAI) against influenza A strains (H1N1, H3N2)

  1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60

• Microneutralization (MN) titers against influenza A strains (H1N1, H3N2)

  1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60

• Hemagglutination Inhibition (HAI) against influenza B strains (B-Victoria lineage, B/Yamagata lineage)

  1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60

• Microneutralization (MN) titers against influenza B strains (B-Victoria lineage, B/Yamagata lineage)

  1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60

• Maximum titer value (Cmax)

  1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60

Study Arms (8)

SAB-176 1 mL

EXPERIMENTAL

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

Drug: Single Ascending Dose of SAB-176

Placebo 1mL

PLACEBO COMPARATOR

Normal Saline

Drug: Single Ascending Dose of Placebo

SAB-176 3mL

EXPERIMENTAL

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

Drug: Single Ascending Dose of SAB-176

Placebo 3mL

PLACEBO COMPARATOR

Normal Saline

Drug: Single Ascending Dose of Placebo

SAB-176 5mL

EXPERIMENTAL

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

Drug: Single Ascending Dose of SAB-176

Placebo 5mL

PLACEBO COMPARATOR

Normal Saline

Drug: Single Ascending Dose of Placebo

SAB-176 20mL

EXPERIMENTAL

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

Drug: Single Ascending Dose of SAB-176

Placebo 20mL

PLACEBO COMPARATOR

Normal Saline

Drug: Single Ascending Dose of Placebo

Interventions

Single Ascending Dose of SAB-176 DRUG

Single ascending dose

Also known as: SAB-176

SAB-176 1 mL; SAB-176 20mL; SAB-176 3mL; SAB-176 5mL

Single Ascending Dose of Placebo DRUG

Single ascending dose

Also known as: Placebo

Placebo 1mL; Placebo 20mL; Placebo 3mL; Placebo 5mL

Eligibility Criteria

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

You may qualify if:

• \. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment.
• \. Completion and review of assessment of understanding test (achieved \> 70% accuracy).
• \. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. 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.
• \. Willing to use an acceptable method of contraception during the study and for 2 months following investigational product administration. If a barrier method is the contraceptive of choice, concurrent use of a spermicide will be recommended.
• \. Body mass index (BMI) between 19 and 35 kg/m2. 8. Agree to refrain from blood donation during the study and for at least 12 months (1 year) following injection with the study drug.

You may not qualify if:

• \. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other condition that might place the subject at increased risk of adverse events); study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
• \. Clinically significant abnormalities on physical examination that, in the PI's opinion, would place the subject at undue risk and/or preclude full evaluation of potential adverse events.
• \. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or inherited or acquired immunodeficiency (including IgA deficiency; defined by serum IgA \<7 mg/dL).
• \. Women who are pregnant or planning to become pregnant during the study period plus 2 months beyond the last received dose, and currently nursing women.
• \. History of buttock enhancement (e.g., silicone enhancement or implants) that may interfere with intramuscular injections.
• \. Participation in research involving another investigational product (defined as receipt of an investigational product such as a drug or vaccine or exposure to an invasive investigational device) within 30 days prior to dosing or any time through the last study safety visit.
• \. Receipt of any unapproved immunizations or vaccines within 30 days prior to planned dosing.
• \. Positive blood test for HBsAg, HCV, or HIV-1/2. 9. Clinically significant abnormalities on basic laboratory screening. 10. Moderate or severe influenza requiring hospitalization in the 30 days prior to planned dosing.
• \. Receipt of any blood product (e.g., RhoGam, IVIG) within 120 days prior to planned dosing.
• \. Use of other drugs that, in the opinion of the investigator, could complicate the safety assessment of SAB-176 (e.g., medications or over-the-counter vitamins or supplements formulated in bovine gelatin).
• \. Vaccination against influenza less than 90 days prior to product administration.
• \. Known autoimmune condition requiring therapy more intensive than intermittent nonsteroidal anti-inflammatories in the 6 months prior to planned dosing (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease).
• \. Chronic respiratory disease including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen.
• \. Chronic asthma requiring the use of oral steroids or hospitalization in the last six months; inhaled steroids are permitted.
• \. Receipt of pooled immunoglobulin or plasma within 30 days prior to planned dosing.

Sponsors & Collaborators

• SAb Biotherapeutics, Inc.: lead

Study Sites (1)

Naval Medical Research Command (NMRC)

Bethesda, Maryland, 20889, United States

Location

Study Officials

• Nehkonti Adams, MD

  Naval Medical Research Command (NMRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 30, 2024
• Study Start: April 22, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)