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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
426
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.
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.
Austin Clinical Research Unit
Austin, Texas, United States
RECRUITINGIncident 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.
Time frame: 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.
Time frame: 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)
Time frame: Day 7 or 8
Bacterial eradication (Part 3)
Bacterial eradication rate (% of participants with absent bacterial culture)
Time frame: Day 7 or 8
Early clinical cure (Part 3)
Clinical cure rate (% of participants with bulbar conjunctival injection and mucopurulent discharge score are zero)
Time frame: Day 3 or 4
Early bacterial eradication (Part 3)
Bacterial eradication rate (% of participants with absent bacterial culture)
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Time frame: Day 3 or 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.
Time frame: From Day 1 to Day 7 or 8
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.
Time frame: From Day 1 to Day 7 or 8