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Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With N. Gonorrhoeae in Healthy Males

NCT03222401 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-08

No results posted yet for this study

Summary

Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject. Subjects who meet the enrollment criteria will be randomized to one of four open-label groups: Control (no treatment) or treatment with F598 at one of three doses. Following F598 administration or assignment to the Control group, subjects must return to the study site for inoculation with N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they will enter the observation phase and will return to the study site daily for up to 5 days. At the end of the observation phase, definitive antibiotic therapy will be administered. A follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory interaction will occur with the subjects 7-10 days after the follow-up to confirm the subject's response. A final visit will occur approximately 8 weeks after inoculation.

Conditions

  • Neisseria Gonorrhoeae

Interventions

DRUG

1 mg/kg single infusion of F598

1 mg/kg single infusion of F598

DRUG

3 mg/kg single infusion of F598

3 mg/kg single infusion of F598

DRUG

10 mg/kg single infusion of F598

10 mg/kg single infusion of F598

Sponsors & Collaborators

  • Alopexx Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Hal Landy, MD · Alopexx Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2018-03-02
Completion
2018-03-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03222401 on ClinicalTrials.gov