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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%; Drug: VVN461 Ophthalmic Solution 0.25%; Drug: VVN461 Ophthalmic Solution Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 to 50 years at the time of signing the informed consent form.
• Males weighing ≥ 50.0kg and females ≥ 45.0kg; and with a body mass index (BMI = weight/height squared) of 19-26 kg/m2 (including thresholds).
• Best-corrected visual acuity (BCVA) ≥ 0.8 (standard logarithmic scale) in both eyes; intraocular pressure of 11-21 mmHg (including threshold) in both eyes; and slit-lamp examination of the anterior segment of the eye and funduscopic examination (funduscopic photographs) with no significant abnormality or an abnormality judged by the investigator to be not clinically significant.
• No clinically significant medical history of the liver, kidneys, gastrointestinal tract, nervous system, respiratory system (e.g., asthma, exercise-induced asthma, chronic obstructive pulmonary disease), hematological and lymphatic system, musculoskeletal system, rheumatological immunity, psychiatric abnormalities and metabolic abnormalities
• Physical examination, vital signs, 12-lead electrocardiogram and laboratory tests at screening are within normal values or the abnormalities are not clinically significant.

Exclusion Criteria:

• Known hypersensitivity or contraindications to the study drug or its components
• Anatomical anomalies in either eye
• History of eye surgery (other than blepharoplasty) or laser treatment of the eye (including keratoconus) in either eye
• Blepharoplasty on either eye within 3 months prior to screening
• History of subchoroidal or vitreous injection in either eye
• Infectious eye disease, immunological eye disease, inflammatory eye disease or ocular trauma in either eye within three months prior to screening;
• Use of topical ophthalmic medications (including artificial tears, proprietary drops and OTC ophthalmic medications) in either eye within 1 month prior to screening
• Using contact lens in either eye within 14 days prior to screening or unable to discontinue the use of contact lens during the study
• A history of eye disease such as glaucoma, corneal opacity, corneal degeneration, corneal dystrophy, uveitis, fundopathy, or other ophthalmic disease in either eye, which is assessed by the investigator to be contraindicated for participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VVN461, 1.0%; VVN461 Ophthalmic Solution, 1.0%	Drug: VVN461 Ophthalmic Solution 1.0%; VVN461, 1.0%
Experimental: VVN461, 0.5%; VVN461 Ophthalmic Solution, 0.5%	Drug: VVN461 Ophthalmic Solution 0.5%; VVN461, 0.5%
Experimental: VVN461, 0.25%; VVN461 Ophthalmic Solution, 0.25%	Drug: VVN461 Ophthalmic Solution 0.25%; VVN461, 0.25%
Placebo Comparator: Vehicle; VVN461 Ophthalmic Solution, Placebo	Drug: VVN461 Ophthalmic Solution Placebo; Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Incidence of adverse events	Baseline to Day 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum blood level	Tmax	Maximum seen over Days 1 to 9
Area under the curve of blood levels until last observation	AUC0-last	Integrated over Days 1 to 9
Area under the curve of blood levels extrapolated to infinity	AUC0-inf	Integrated over Days 1 to 9
Half life of drug in blood	t1/2	Integrated over Days 1 to 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration of drug in blood	Cmax	Integrated over Days 1 to 9

Collaborators and Investigators

• Sponsor: VivaVision Biotech, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: VVN461-CCS-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No