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COMPLETED
NCT07779902
PHASE1

Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers

Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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

DRUG

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