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Bacterial ConjunctivitisPhase 1/2NCT07565103

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

A Phase 1/2 study testing SUM-191 in people with Bacterial Conjunctivitis, run by Senju USA, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bacterial Conjunctivitis
What is being tested?
SUM-191
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
426 participants
Where
1 siteUnited States
Study dates
25 Jun 2026to 15 Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • The participant has used any topical ocular or systemic anti-inflammatory agents within 72 hours of the first dose in either eye.
  • The participant has any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis), that may affect the trial parameters, per investigator's discretion.
  • The participant has any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, or organ or bone marrow transplantation.
  • The participant has used any IP within 30 days or 5 half-lives, whichever is longer, prior to the first dose of IP.
  • The participant has been enrolled in a clinical trial (including vaccine studies) that, in the investigator's opinion, may impact this trial.
  • The participant is involved in the planning and/or conduct of the trial (applies to the sponsor, contract research organizations, and trial center staff, etc).
  • The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, hepatitis A (antihepatitic A virus IgM), or human immunodeficiency virus types 1 or 2 antibodies at Screening (Part 1 and Part 2).
  • The participant is an active smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before IP dosing (Part 1 and Part 2).
  • The participant has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >14 units per week for male participants and 7 units of alcohol per week for female participants (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits) 6 months prior to Screening in Parts 1 and 2.
  • The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current nicotine use/exposure) at Screening or Day -1 in Parts 1 and 2.
  • The participant has donated blood or blood products >450 mL within 30 days before IP dosing.
  • Male participant with a QTcF >450 ms or female participants with a QTcF >470 ms at Screening or on Day -1 safety ECG in Parts 1 and 2.
  • Additional exclusion criteria for Part 3:
  • The participant has a positive test result for drugs of abuse at Visit 1.
  • The participant has a positive result of a rapid adenovirus test at Visit 1.
  • The participant has a previous treatment for current bacterial conjunctivitis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mizue Takahara contact

310-935-0505

SUM191@senju-usa.com

Satoshi Yamamoto contact

310-935-0505

SUM191@senju-usa.com

United States1 site, 1 recruiting

  • Austin Clinical Research Unit

    Austin, Texas, 78744

    Mizue Takahara, 512-447-2985, crgstudyinfo.sm@thermofisher.com

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
SUM-191, Placebo
Medical subject headings
Conjunctivitis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUM-191Drug

    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.

  • PlaceboDrug

    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 groups in NCT07565103
Study groupRoleWhat they receive
SUM-191ExperimentalParticipants will receive SUM-191.
Receives: Drug: SUM-191
PlaceboPlacebo comparatorParticipants will receive Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. Clinical cure (Part 3)

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

    Measured: Day 7 or 8

Secondary outcomes (5)

  1. Bacterial eradication (Part 3)

    Bacterial eradication rate (% of participants with absent bacterial culture)

    Measured: Day 7 or 8

  2. Early clinical cure (Part 3)

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

    Measured: Day 3 or 4

  3. Early bacterial eradication (Part 3)

    Bacterial eradication rate (% of participants with absent bacterial culture)

    Measured: Day 3 or 4

  4. Incident of Adverse Events (AEs) (Part 3)

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

    Measured: From Day 1 to Day 7 or 8

  5. Severity of Adverse Events (AEs)

    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.

    Measured: From Day 1 to Day 7 or 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start25 Jun 2026
  3. Primary completion15 Aug 2028 (estimated)
  4. Study completion15 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
426 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565103
Sponsor's protocol ID
SUM-191-01
Status last verified
Jun 2026
First submitted
16 Apr 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SUM-191 in people with Bacterial Conjunctivitis, run by Senju USA, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mizue Takahara (310-935-0505, SUM191@senju-usa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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