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RECRUITING
NCT07565103
PHASE1/PHASE2

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

Sponsor: Senju USA, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SUM-191 in Healthy Participants and in Participants With Bacterial Conjunctivitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2026-06-25

Completion Date

2028-08-15

Last Updated

2026-06-30

Healthy Volunteers

Yes

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.

Locations (1)

Austin Clinical Research Unit

Austin, Texas, United States