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Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis

NCT07565103 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2026-05-04

No results posted yet for this study

Summary

This is a seamless Phase I/II, randomized, double-masked, placebo-controlled, multicenter trial to evaluate single and multiple-dose safety and tolerability of SUM-191 in healthy participants in Parts 1 (SAD) and 2 (MAD) ; and multiple-dose efficacy and safety of SUM-191 in participants with bacterial conjunctivitis in Part 3.

Conditions

  • Bacterial Conjunctivitis

Interventions

DRUG

SUM-191

Part 1 (SAD): SUM-191 is administrated a single dose topically. Part 2 (MAD): SUM-191 is administrated TID topically for 6 days. Part 3: SUM-191 is administrated TID topically for 6 days.

DRUG

Placebo

Part 1 (SAD): Placebo is administrated a single dose topically. Part 2 (MAD): Placebo is administrated TID topically for 6 days. Part 3: Placebo is administrated TID topically for 6 days.

Sponsors & Collaborators

  • Senju USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-08-15
Completion
2028-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07565103 on ClinicalTrials.gov