The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in healthy subjects.
This is a Phase I, randomised, double-masked, placebo-controlled study of G01 Eye Drops in healthy male and female subjects. This study comprises a single ascending dose part (single ocular application of two drop) and a multiple ascending dose part (two drop three times daily for seven consecutive days). Three ascending dose levels will be included in both parts. In both the single and multiple ascending dose parts, each ascending cohort will enroll 6 subjects receiving G01 Eye Drops and 2 subjects receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
all subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Number of Participants With Adverse Events
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be evaluated for seriousness, severity, relationship to study drug, action taken, outcome, and classification as treatment-emergent adverse events (TEAEs).
Time frame: From informed consent through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Safety assessments include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. The number and percentage of participants with clinically significant abnormali
Time frame: From baseline through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
Serum Concentration of G01 Eye Drops
Serum drug concentrations of G01 Eye Drops will be measured and analyzed to characterize the serum concentration profiles in single-administration and multiple-administration cohorts. Blood samples for concentration analysis will be collected at scheduled time points throughout the study period. The scheduled sampling time points may be adjusted appropriately according to the actual detection results during the study.
Time frame: Day 1, Day 2, Day 3 for single-administration cohorts; Day 1, Day 5, Day 6, Day 7, Day 8, Day 9 for multiple-administration cohorts
Number of Participants With Positive Anti-Drug Antibody (ADA)
Blood samples will be collected at scheduled time points to detect anti-drug antibody (ADA) against G01 Eye Drops. The number and percentage of participants with positive ADA results will be summarized in single-administration and multiple-administration cohorts to evaluate the immunogenicity of G01 Eye Drops.
Time frame: Day 1, Day 3, Day 14 for single-administration cohorts; Day 1, Day 8, Day 14 for multiple-administration cohorts
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All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list , which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.