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

Stopped early · Phase 2

Conditions studied: Neisseria Gonorrhoeae

In brief

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.

Key facts

Study ID

NCT03222401

Run by

Alopexx Pharmaceuticals, LLC

People needed

10

Starts

2017-11-29

Expected to finish

2018-03-02

Last updated by the study team

2019-02-08

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male between the ages of 18 and 35 years
• Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)
• Able and willing to provide written informed consent
• Able and willing to attend all study visits and follow-up visit during the week after treatment
• Willing to abstain from masturbation during the 6 days after inoculation
• Willing to abstain from all sexual activity during the course of the study
• No clinically significant abnormalities on physical examination
• No clinically significant abnormalities in serum chemistries, hematology and urinalysis
• Urine negative for chlamydia, gonorrhea and trichomonas
• No history of sexually transmitted infections (STIs), including syphilis and hepatitis B (HBV) \& hepatitis C (HCV)
• Negative human immunodeficiency virus (HIV), syphilis and HCV serologies
• Negative HBV core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody)
• No history of bleeding diathesis
• No history of seizures (due to reports of seizures with ciprofloxacin)
• No history of cancer, except basal cell carcinoma of the skin more than 5 years ago
• No history of drug abuse
• No history of psychiatric disorders, except depression controlled by medication
• No history of genitourinary surgery

You may not qualify if…

• Student or employee under the direct supervision of any of the study investigators
• Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection
• Sickle cell disease
• Psychiatric disorders that would interfere with the ability of the subject to comply with the requirements of the protocol
• Unstable depression (defined as receiving either <3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements
• Heart murmur or heart disease
• Anatomic abnormality of the urinary tract
• Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days
• Chemotherapy within the past year
• Current steroid use, except for topical application
• Allergy to penicillin, cephalosporins, ciprofloxacin or to lidocaine
• Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study.
• Medications not permitted with cefixime or ceftriaxone include:
• Warfarin
• Probenecid
• Aspirin
• Diuretics such as furosemide
• Aminoglycoside antibiotics
• Chloramphenicol
• Medications not permitted with ciprofloxacin include:
• Tizanidine
• Theophylline
• Warfarin
• Glyburide
• Cyclosporine

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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