Botulism Prevention

Last updated: December 12, 2022
Sponsor: Ology Bioservices
Overall Status: Active - Recruiting

Phase

2

Condition

Vaccines

Treatment

N/A

Clinical Study ID

TX304030
G03 52 01 002
  • Ages 18-65
  • All Genders

Study Summary

A Phase 2, multicenter, randomized, double-blinded, placebo-controlled study to evaluate repeat dose (50 mg and 100 mg) of G03-52-01 administered by IM injection(s) in adult subjects. Approximately 375 subjects will be enrolled in this study.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Healthy adult 18 to 65 years of age
  • Able and willing to comply and be available for all protocol procedures and follow-up for the duration of the study.

Exclusion

Exclusion Criteria

  • History of any uncontrolled or chronic medical conditions that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject based on Investigator judgement.
  • Known history of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
  • Known allergic reactions to any of the study product components present in the formulation or in the processing.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

A Phase 2, randomized, double-blind, placebo-controlled repeat dose trial

Connect with a study center

  • AMR Lexington

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

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