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

NCT03222401 | Terminated Phase 2 FDA Drug

• 1 other identifier: AP-GC-201-16
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neisseria Gonorrhoeae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Assess the impact of F598 on urethritis symptoms caused by N. gonorrhoeae infection

  Up to 6 weeks

• Incidence of Treatment-Emergent Adverse Events [Safety and Immunogenicity]

  Through study completion, an average of two months

• Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood

  Through study completion, an average of two months

• Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood

  Through study completion, an average of two months

• Pharmacokinetic evaluation by measuring change from baseline in the concentration of F598 in the blood

  Through study completion, an average of two months

Study Arms (4)

Control Group

NO INTERVENTION

Control subjects will not receive an infusion or placebo

1 mg/kg single infusion of F598

EXPERIMENTAL

1 mg/kg single infusion of F598

Drug: 1 mg/kg single infusion of F598

3 mg/kg single infusion of F598

EXPERIMENTAL

3 mg/kg single infusion of F598

Drug: 3 mg/kg single infusion of F598

10 mg/kg single infusion of F598

EXPERIMENTAL

10 mg/kg single infusion of F598

Drug: 10 mg/kg single infusion of F598

Interventions

1 mg/kg single infusion of F598 DRUG

1 mg/kg single infusion of F598

Also known as: F598

1 mg/kg single infusion of F598

3 mg/kg single infusion of F598 DRUG

3 mg/kg single infusion of F598

Also known as: F598

3 mg/kg single infusion of F598

10 mg/kg single infusion of F598 DRUG

10 mg/kg single infusion of F598

Also known as: F598

10 mg/kg single infusion of F598

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Healthy male between the ages of 18 and 35 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Alopexx Pharmaceuticals, LLC: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Hal Landy, MD

  Alopexx Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 19, 2017
• Study Start: November 29, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)