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Completed
NCT07779902
Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers
Conditions: Healhty
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 48
Sponsor: Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.
Location: Affiliated Hospital of Jining Medical University Jining Shandong
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.
Eligibility Criteria
Inclusion Criteria:
* Healthy adults aged 18 to 50 years (inclusive) at the time of signing the informed consent form, of either sex.
* Body weight ≥50 kg for males and ≥45 kg for females at screening; body mass index (BMI) within the range of 19.0 to 28.0 kg/m² (inclusive), calculated as body weight (kg) / height² (m²); vital signs, laboratory tests, and physical examination findings are either within normal limits or deemed clinically insignificant (abnormal without clinical relevance).
* Best-corrected visual acuity (BCVA) ≥83 letters in both eyes (with refractive error ≤ -6.0 D); intraocular pressure (IOP) between 10 and 21 mmHg (inclusive) in both eyes, with an interocular IOP difference \2 punctate corneal fluorescein staining spots, tear film break-up time \[TBUT\] \5 cigarettes per day within 3 months prior to screening, or inability to refrain from smoking throughout the entire study period.
* Suspected or confirmed alcohol dependence; average daily alcohol intake exceeding 2 units per day within 3 months (1 unit = 10 mL of pure ethanol, equivalent to 200 mL of beer at 5% alcohol, 25 mL of spirits at 40% alcohol, or 83 mL of wine at 12% alcohol); or positive alcohol breath test; or inability to abstain from alcohol during the study period.
* Vital signs outside the following ranges: systolic blood pressure \
Source: ClinicalTrials.gov (NCT07779902). StuddyBuddy aggregates publicly available trial information.