Neisseria Gonorrhoeae Clinical Trial
Official title:
IGHID 11705 A Randomized, Open-label, Controlled Clinical Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With Neisseria Gonorrhoeae in Healthy Male Subjects
Verified date | February 2019 |
Source | Alopexx Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | March 2, 2018 |
Est. primary completion date | March 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Alopexx Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae | Following the inoculation of N. gonorrhoeae, assess efficacy based of the proportion of infected subjects in each treatment group | Through study completion, an average of two months | |
Secondary | Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection | Urethritis signs as measured on targeted physical examination or symptoms reported by subject | Up to 6 weeks | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Immunogenicity] | Monitor the treatment-emergent adverse events, infusion-associated reactions and anti-drug antibodies following administration of F598 | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | Cmax: Observed maximum serum concentration | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | Tmax: Time to attain maximum serum concentration | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | T 1/2: Elimination half-life | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | AUC: Area under the serum concentration-time curve | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | CL: Total body clearance of F598 from plasma | Through study completion, an average of two months | |
Secondary | Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood | V: Volume of F598 distribution at steady state | Through study completion, an average of two months | |
Secondary | Pharmacodynamics: Associations between the PD parameters and infection rate | Blood samples for serum bactericidal activity following administration of F598 | Through study completion, an average of two months | |
Secondary | Pharmacodynamics: Associations between the PD parameters and infection rate | Blood samples for complement fixation following administration of F598 | Through study completion, an average of two months |
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