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

Part of paid clinical trials in Austin, Texas.

Sponsor
Senju USA, Inc.
Study ID
NCT07565103
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bacterial Conjunctivitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SUM-191 — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Aug 15, 2028
Completion
Aug 15, 2028

Study Design

Enrollment
426 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SUM-191
    Participants will receive SUM-191.
  • Placebo Comparator: Placebo
    Participants will receive Placebo

Primary Outcome Measure

Incident of Adverse Events (AEs) (Part 1 and Part 2) [ Time Frame: Part 1: From Day 1 to Day 7 Part 2: From Day 1 to Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Austin Clinical Research UnitAustinTexas78744
Mizue Takahara
[email protected]
512-447-2985

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By research site
Austin Clinical Research Unit· Austin, TX

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