Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
Status:
Completed
Trial end date:
2015-12-30
Target enrollment:
Participant gender:
Summary
This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male
and female subjects, between the ages of 18 and 55, who are in good health and meet all
eligibility criteria. The study is designed to assess the safety and efficacy of an
antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to
adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.
Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of
AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is
also known as ETX0914.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)