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

NCT07565103 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: SUM-191-01
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Incident of Adverse Events (AEs) (Part 1 and Part 2)

  An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

  Part 1: From Day 1 to Day 7 Part 2: From Day 1 to Day 14

• Severity of Adverse Events (AEs) (Part 1 and Part 2)

  The severity (or intensity) of an AE refers to the extent to which it affects the participant's daily activities and will be classified as mild, moderate, or severe using the following criteria: * Mild: These events require minimal or no treatment and do not interfere with the participant's daily activities. * Moderate: These events result in a low level of inconvenience or require minor therapeutic measures. Moderate events may cause some interference with normal functioning. * Severe: These events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.

  Part 1: From Day 1 to Day 7 Part 2: From Day 1 to Day 14

• Clinical cure (Part 3)

  Clinical cure rate (% of participants with bulbar conjunctival injection and mucopurulent discharge score are zero)

  Day 7 or 8

Secondary Outcomes (5)

• Bacterial eradication (Part 3)

  Day 7 or 8

• Early clinical cure (Part 3)

  Day 3 or 4

• Early bacterial eradication (Part 3)

  Day 3 or 4

• Incident of Adverse Events (AEs) (Part 3)

  From Day 1 to Day 7 or 8

• Severity of Adverse Events (AEs)

  From Day 1 to Day 7 or 8

Study Arms (2)

SUM-191

EXPERIMENTAL

Participants will receive SUM-191.

Drug: SUM-191

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo

Drug: Placebo

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.

SUM-191

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is able to provide signed and dated, written informed consent prior to any trial specific procedures.
• The participant understands and is able and willing to fully comply with trial procedures and restrictions.
• The participant is a male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol, or is a female of non-childbearing potential.
• The male participant must agree not to donate sperm 90 days after last dose of IP and female participant must agree not to donate egg 30 days after last dose of IP.
• The participant is willing to discontinue wearing a contact lens for the duration of the trial.
• Additional criteria for Parts 1 and 2:
• The participant is a healthy male or female, aged 18 years and older.
• The participant has triglyceride levels less than 150 mg/dL at Screening.
• The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital signs, 12-lead ECG results, and physical examination findings at Screening and Day -1.
• Additional criteria for Part 3:
• The participant is a male or female, aged 18 years and older.
• The participant has a clinical diagnosis of bacterial conjunctivitis in at least one eye.
• The participant has a BCVA of 20/200 Snellen equivalent or better in each eye as per standard of care assessment.

You may not qualify if:

• The participant has a current or recurrent disease that could affect the action, absorption, or disposition of the IP, or clinical or laboratory assessments, per investigator's discretion.
• The participant has a current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IP or procedures.
• The participant has any current active infections (except bacterial conjunctivitis in Part 3), including localized infections, or any recent history (within 1 week prior to IP administration) of infections (including SARS-CoV-2), cough or fever, herpes, or a history of recurrent or chronic infections.
• The participant has any clinically important illness, medical/surgical procedure, or trauma within 2 weeks of the first administration of IP or planned surgical procedure during the trial period.
• The participant has a known or suspected intolerance or hypersensitivity to the IP, closely related compound, any of the stated ingredients or its vehicle.
• The participant has any history of or active sign of any intraocular inflammation in either eye caused by autoimmune or systemic etiology OR has an active or one month prior to Check-in for Parts 1 and 2 and Visit 1 for Part 3, an infectious or allergy-induced intraocular inflammation in either eye.
• The participant has a presence of corneal abrasion or corneal ulcer in either eye.
• The participant has any presence of blepharoconjunctivitis in either eye.
• The participant has an active or a history of ocular herpes (including herpetic corneal ulcer and ophthalmic herpes zoster) in the eye(s) that will receive IP.
• The participant has a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or severe dry eye syndrome or presence of corneal epithelial defect or any significant corneal opacity at Screening or at Day 1 (predose) in Parts 1 and 2 and at Visit 1 in either eye.
• The participant has nasolacrimal duct obstruction or dacryocystitis at Screening or Day -1 in Parts 1 and 2 and at Visit 1 in Part 3, in the eye(s) that will receive IP.
• The participant has a history of any ocular surgeries within 3 months prior to Day -1 in Parts 1 and 2 and Visit 1 in the eye(s) that will receive IP.
• The participant has a significant, active condition of the retina requiring treatment in either eye during the trial.
• The participant has an uncontrolled glaucoma defined as IOP ≥25 mmHg despite maximal medical therapy in either eye.
• The participant has used any topical ocular or systemic antibiotics within 72 hours of the first dose in either eye.

Sponsors & Collaborators

• Senju USA, Inc.: lead

Study Sites (1)

Austin Clinical Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Central Study Contacts

Mizue Takahara

CONTACT

310-935-0505; SUM191@senju-usa.com

Satoshi Yamamoto

CONTACT

310-935-0505; SUM191@senju-usa.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)