NCT06906198

Pharmacokinetics of VVN461 Ophthalmic Solution

A Randomized, Double-Masked, Vehicle-Controlled, Single-Center Phase 1 Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of 0.25%, 0.5% and 1.0% VVN461 Ophthalmic Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double-masked, randomized, vehicle-controlled study conducted in China in adult healthy subjects

Detailed description

This is a Phase I, randomized, double-masked, vehicle-controlled study to evaluate the safety, tolerability and pharmacokinetics of 0.25%, 0.5% and 1.0% VVN461 Ophthalmic Solution in healthy male and female volunteers in China. The study consisted of a screening period (D-7 to D-1), a baseline visit (D-1), a single-dose period (D1), QID multi-dose period (D2 to D5), six times daily multi-dose period (D6 to D9), discharge (D10), and a follow-up/EOS (D16,+1D). During the single-dose period, subjects will receive one drop of VVN461 eye drops (0.25%, 0.5%, or 1.0%) or vehicle in the study eye. For the multi-dose period, subjects will receive one drop of VVN461 eye drop (0.25%, 0.5% or 1.0%) or vehicle in the study eye four or six times a day. PK blood samples will be collected before and after dosing at D1, D5 and D9.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VVN461 Ophthalmic Solution 1.0%	VVN461, 1.0%
DRUG	VVN461 Ophthalmic Solution 0.5%	VVN461, 0.5%
DRUG	VVN461 Ophthalmic Solution 0.25%	VVN461, 0.25%
DRUG	VVN461 Ophthalmic Solution Placebo	Vehicle

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-05-10
• Completion: 2023-12-22
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: China