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Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers
Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.
Summary
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.
Official title: Phase I, Single-center, Randomized, Double-masked, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of G01 Eye Drops Following Single and Multiple Administrations in Healthy Subjects.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-12-12
Completion Date
2025-06-28
Last Updated
2026-08-21
Healthy Volunteers
Yes
Conditions
Interventions
G01 Eye Drops 100 µg/mL SAD
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
G01 Eye Drops 200 µg/mL SAD
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
G01 Eye Drops 400 µg/mL SAD
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
G01 Eye Drops 100 µg/mL MAD
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.
G01 Eye Drops 200 µg/mL MAD
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.
G01 Eye Drops 400 µg/mL MAD
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.
Placebo of G01 Eye Drops SAD
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list
Placebo of G01 Eye Drops MAD
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.
Locations (1)
Affiliated Hospital of Jining Medical University
Jining, Shandong, China