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

NCT04471038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-01-06

Study results available
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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.

Conditions

  • Influenza Type A
  • Influenza Type B
  • Influenza

Interventions

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

Sponsors & Collaborators

  • SAb Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Rebecca N Wood-Horrall, MD · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-04-19
Completion
2021-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471038 on ClinicalTrials.gov