Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis (NCT07565103) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
United States426 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incident of Adverse Events (AEs) (Part 1 and Part 2)
Timeframe: 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)
Timeframe: Part 1: From Day 1 to Day 7 Part 2: From Day 1 to Day 14
✕. 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.