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.
• 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.