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Study to Evaluate the Effect of a Single Oral Dose of Zoliflodacin 3 g on Testicular Function in Healthy Adult Men

NCT07640477 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-10

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of zoliflodacin on testicular function in healthy adult men. Participants will be screened within 21 days before randomization (Day 1), including collection of 2 semen samples (each collected after a ≥48 hours and ≤7 days ejaculation-free period). Approximately 220 participants who provide written informed consent and meet all inclusion and no exclusion criteria will be enrolled and randomized in a 1:1 fashion to receive a single dose of either zoliflodacin 3 g or placebo administered as an oral suspension on Day 1.

Each participant will be contacted by telephone at Week 1 and at Week 7 post dosing to review adverse events (AEs), concomitant medications and procedures, and genitourinary symptoms.

Each participant will return to the trial site at Week 13 for collection of 2 semen samples (each collected after a ≥48 hours and ≤7 days ejaculation-free period). A serum sample will also be collected for hormone testing (luteinizing hormone \[LH\], follicle-stimulating hormone \[FSH\], and total testosterone) at Week 13 to support biological interpretation of any decrease in sperm concentration.

Participants who do not have a ≥50% decrease from baseline in sperm concentration at Week 13 will complete the trial at Week 13 (end of trial). Participants with a ≥50% decrease from baseline in sperm concentration at Week 13 will return to the trial site at Week 26 for collection of 2 semen samples (independent ejaculates, each collected after a ≥48 hours and ≤7 days ejaculation-free period) for evaluation of the reversibility of the Week 13 finding, following completion of a one additional spermatogenic cycle post completion of dosing/drug exposure (FDA 2018) (end of trial).

All Adverse Events, medications, and procedures will be recorded from the signing of the informed consent form (ICF) through the end-of-trial visit (Week 13, Week 26, or Early Termination)

Conditions

  • Testicular Abnominalies

Interventions

DRUG

Zoliflodacin

Oral suspension of Zoliflodacin 3g

DRUG

Placebo

Oral suspension of matching placebo

Sponsors & Collaborators

  • Global Antibiotics Research and Development Partnership

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640477 on ClinicalTrials.gov