Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03222401
Status:
TERMINATED
Last Update Posted:
2019-02-08
First Post:
2017-07-07
Brief Title:
Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With N Gonorrhoeae in Healthy Males
Sponsor:
Alopexx Pharmaceuticals LLC
Organization:
AlopexxPharma
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis suggested that the trial as designed was not adequately powered to detect a therapeutic effect
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects response A final visit will occur approximately 8 weeks after inoculation
Detailed Description:
The study is comprised of 8 phases
1 Screening Visits 1 and 2
2 F598 administration Visit 3
3 Inoculation Visit 4
4 Observation Visits 5 - 8 as needed
5 Definitive antibiotic treatment Visit 9
6 Test of cure Visit 10
7 Confirmatory interaction Visit 11
8 Final pharmacokinetic PKpharmacodynamic PDanti-drug antibody determination Visit 12
For the purposes of standardization Day 1 of the study will be considered the day of inoculation
During the Screening phase prospective subjects will undergo informed consent and will be reviewed for their compatibility with the eligibility criteria Those subjects who meet all of the Inclusion criteria and none of the Exclusion criteria will be enrolled Following enrollment subjects must undergo a repeat urine screen for C trachomatis N gonorrhoeae and T vaginalis Days -17 to -4
If the second urine screening test is negative subjects will enter the F598 administration phase Subjects will return to the study site and 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 Thus F598 will be administered on any one of Days -12 to -2
During the inoculation phase subjects will return to the study site and receive an inoculum of N gonorrhoeae in the anterior urethra A third and final urine screen for C trachomatis N gonorrhoeae and T vaginalis will be obtained immediately before inoculation
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 for a physical examination in particular for evidence of urethral discharge and a urine sample for evidence of infection NAAT and culture as well as blood for F598 PKPD and safety labs
The observation phase will end and definitive antibiotic therapy will be administered when any one of four criteria is met
1 The subject requests antibiotic treatment
2 The subject is found to by symptomatic discharge urethral discomfort
3 The subject has reached Day 6 of the study
Thus depending on the circumstances definitive antibiotic therapy can be administered between Days 2 - 6 inclusive
A follow-up visit at the study site will be conducted 3 - 5 days after definitive antibiotic therapy has been administered to ensure treatment response Thus depending on when the subject received antibiotics this visit could occur between Days 5 - 11 inclusive A physical examination will be performed and urine for evidence of infection NAAT as well as blood for F598 PKPD will be obtained
A confirmatory interaction with the subject will occur at the study site 7 - 10 days after the follow-up visit to confirm the subjects response and answer any questions the subject may have Thus depending on when the subject had his follow-up visit the confirmatory visit could occur between Days 12 - 21 inclusive Blood for F598 PKPD anti-F598 antibodies and safety labs will be obtained
A final visit will occur approximately 8 weeks after inoculation days 52 - 60 to obtain serum for PKPD and anti-F598 antibodies
1 Screening Visits 1 and 2
2 F598 administration Visit 3
3 Inoculation Visit 4
4 Observation Visits 5 - 8 as needed
5 Definitive antibiotic treatment Visit 9
6 Test of cure Visit 10
7 Confirmatory interaction Visit 11
8 Final pharmacokinetic PKpharmacodynamic PDanti-drug antibody determination Visit 12
For the purposes of standardization Day 1 of the study will be considered the day of inoculation
During the Screening phase prospective subjects will undergo informed consent and will be reviewed for their compatibility with the eligibility criteria Those subjects who meet all of the Inclusion criteria and none of the Exclusion criteria will be enrolled Following enrollment subjects must undergo a repeat urine screen for C trachomatis N gonorrhoeae and T vaginalis Days -17 to -4
If the second urine screening test is negative subjects will enter the F598 administration phase Subjects will return to the study site and 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 Thus F598 will be administered on any one of Days -12 to -2
During the inoculation phase subjects will return to the study site and receive an inoculum of N gonorrhoeae in the anterior urethra A third and final urine screen for C trachomatis N gonorrhoeae and T vaginalis will be obtained immediately before inoculation
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 for a physical examination in particular for evidence of urethral discharge and a urine sample for evidence of infection NAAT and culture as well as blood for F598 PKPD and safety labs
The observation phase will end and definitive antibiotic therapy will be administered when any one of four criteria is met
1 The subject requests antibiotic treatment
2 The subject is found to by symptomatic discharge urethral discomfort
3 The subject has reached Day 6 of the study
Thus depending on the circumstances definitive antibiotic therapy can be administered between Days 2 - 6 inclusive
A follow-up visit at the study site will be conducted 3 - 5 days after definitive antibiotic therapy has been administered to ensure treatment response Thus depending on when the subject received antibiotics this visit could occur between Days 5 - 11 inclusive A physical examination will be performed and urine for evidence of infection NAAT as well as blood for F598 PKPD will be obtained
A confirmatory interaction with the subject will occur at the study site 7 - 10 days after the follow-up visit to confirm the subjects response and answer any questions the subject may have Thus depending on when the subject had his follow-up visit the confirmatory visit could occur between Days 12 - 21 inclusive Blood for F598 PKPD anti-F598 antibodies and safety labs will be obtained
A final visit will occur approximately 8 weeks after inoculation days 52 - 60 to obtain serum for PKPD and anti-F598 antibodies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None