We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 81 for:    "Gonorrhea"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03222401
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Neisseria Gonorrhoeae Drug: 1 mg/kg single infusion of F598 Drug: 3 mg/kg single infusion of F598 Drug: 10 mg/kg single infusion of F598 Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Subjects will be enrolled in 6 identical cohorts of 4 subjects each. Within each cohort, subjects will be randomized to:

  1. Control (n=1)
  2. F598, 1 mg/kg (n=1)
  3. F598, 3 mg/kg (n=1)
  4. F598, 10 mg/kg (n=1)
Masking: Single (Participant)
Masking Description: All doses of F598 will be administered on an open-label basis. Investigators will be unblinded, and subjects will be aware if they are randomized to the control group or one of the active dose groups; however, subjects in one of the active dose groups will not be informed of their randomized dosage.
Primary Purpose: Prevention
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
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control Group
Control subjects will not receive an infusion or placebo
Experimental: 1 mg/kg single infusion of F598
1 mg/kg single infusion of F598
Drug: 1 mg/kg single infusion of F598
1 mg/kg single infusion of F598
Other Name: F598
Experimental: 3 mg/kg single infusion of F598
3 mg/kg single infusion of F598
Drug: 3 mg/kg single infusion of F598
3 mg/kg single infusion of F598
Other Name: F598
Experimental: 10 mg/kg single infusion of F598
10 mg/kg single infusion of F598
Drug: 10 mg/kg single infusion of F598
10 mg/kg single infusion of F598
Other Name: F598


Outcome Measures

Primary Outcome Measures :
  1. Assess the efficacy of F598 in preventing an experimental urethral infection with N. gonorrhoeae [ Time Frame: Through study completion, an average of two months ]
    Following the inoculation of N. gonorrhoeae, assess efficacy based of the proportion of infected subjects in each treatment group


Secondary Outcome Measures :
  1. Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection [ Time Frame: Up to 6 weeks ]
    Urethritis signs as measured on targeted physical examination or symptoms reported by subject

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Immunogenicity] [ Time Frame: Through study completion, an average of two months ]
    Monitor the treatment-emergent adverse events, infusion-associated reactions and anti-drug antibodies following administration of F598

  3. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    Cmax: Observed maximum serum concentration

  4. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    Tmax: Time to attain maximum serum concentration

  5. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    T 1/2: Elimination half-life

  6. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    AUC: Area under the serum concentration-time curve

  7. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    CL: Total body clearance of F598 from plasma

  8. Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood [ Time Frame: Through study completion, an average of two months ]
    V: Volume of F598 distribution at steady state

  9. Pharmacodynamics: Associations between the PD parameters and infection rate [ Time Frame: Through study completion, an average of two months ]
    Blood samples for serum bactericidal activity following administration of F598

  10. Pharmacodynamics: Associations between the PD parameters and infection rate [ Time Frame: Through study completion, an average of two months ]
    Blood samples for complement fixation following administration of F598


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy male between the ages of 18 and 35 years
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222401


Contacts
Contact: Julie Williams 617-306-4961 julie.williams@alopexx.com

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Blevins    984-227-2275    NG_outpatient@med.unc.edu   
Sponsors and Collaborators
Alopexx Pharmaceuticals, LLC
Investigators
Study Director: Hal Landy, MD Alopexx Pharmaceuticals, LLC
More Information

Responsible Party: Alopexx Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT03222401     History of Changes
Other Study ID Numbers: AP-GC-201-16
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female