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

• Status: Terminated
• Trial end date: 2018-03-02
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alopexx Pharmaceuticals, LLC

Criteria

Inclusion Criteria:

1. Healthy male between the ages of 18 and 35 years

2. Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)

3. Able and willing to provide written informed consent

4. Able and willing to attend all study visits and follow-up visit during the week after treatment

5. Willing to abstain from masturbation during the 6 days after inoculation

6. Willing to abstain from all sexual activity during the course of the study

7. No clinically significant abnormalities on physical examination

8. No clinically significant abnormalities in serum chemistries, hematology and urinalysis

9. Urine negative for chlamydia, gonorrhea and trichomonas

10. No history of sexually transmitted infections (STIs), including syphilis and hepatitis B (HBV) & hepatitis C (HCV)

11. Negative human immunodeficiency virus (HIV), syphilis and HCV serologies

12. Negative HBV core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody)

13. No history of bleeding diathesis

14. No history of seizures (due to reports of seizures with ciprofloxacin)

15. No history of cancer, except basal cell carcinoma of the skin more than 5 years ago

16. No history of drug abuse

17. No history of psychiatric disorders, except depression controlled by medication

18. No history of genitourinary surgery

Exclusion Criteria:

1. Student or employee under the direct supervision of any of the study investigators

2. Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection

3. Sickle cell disease

4. Psychiatric disorders that would interfere with the ability of the subject to comply with the requirements of the protocol

5. 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

6. Heart murmur or heart disease

7. Anatomic abnormality of the urinary tract

8. Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days

9. Chemotherapy within the past year

10. Current steroid use, except for topical application

11. Allergy to penicillin, cephalosporins, ciprofloxacin or to lidocaine

12. Treatment with medications that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study.

1. Medications not permitted with cefixime or ceftriaxone include:

• Warfarin

• Probenecid

• Aspirin

• Diuretics such as furosemide

• Aminoglycoside antibiotics

• Chloramphenicol

2. Medications not permitted with ciprofloxacin include:

• Tizanidine

• Theophylline

• Warfarin

• Glyburide

• Cyclosporine

• Probenecid

• Phenytoin

• Methotrexate

• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc

• Caffeine-containing medications

• Sucralfate or didanosine chewable or buffered

13. Major organ dysfunction

14. Any significant pre-existing condition preventing full compliance with the study

15. Infection or any serious underlying medical condition that would impair the ability of the subject to receive protocol treatment