NCT04471038

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

A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-176 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: SAb Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	SAB-176	Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
OTHER	Normal Saline	Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2020-07-14
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study