Pharmacokinetics of VVN461 Ophthalmic Solution

NCT ID: NCT06906198

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-12-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VVN461, 1.0%

VVN461 Ophthalmic Solution, 1.0%

Group Type: EXPERIMENTAL

VVN461 Ophthalmic Solution 1.0%

Intervention Type: DRUG

VVN461, 1.0%

VVN461, 0.5%

VVN461 Ophthalmic Solution, 0.5%

Group Type: EXPERIMENTAL

VVN461 Ophthalmic Solution 0.5%

Intervention Type: DRUG

VVN461, 0.5%

VVN461, 0.25%

VVN461 Ophthalmic Solution, 0.25%

Group Type: EXPERIMENTAL

VVN461 Ophthalmic Solution 0.25%

Intervention Type: DRUG

VVN461, 0.25%

Vehicle

VVN461 Ophthalmic Solution, Placebo

Group Type: PLACEBO_COMPARATOR

VVN461 Ophthalmic Solution Placebo

Intervention Type: DRUG

Vehicle

Interventions

VVN461 Ophthalmic Solution 1.0%

VVN461, 1.0%

Intervention Type: DRUG

VVN461 Ophthalmic Solution 0.5%

VVN461, 0.5%

Intervention Type: DRUG

VVN461 Ophthalmic Solution 0.25%

VVN461, 0.25%

Intervention Type: DRUG

VVN461 Ophthalmic Solution Placebo

Vehicle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VivaVision Biotech, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

VVN461-CCS-101

Identifier Type: -

Identifier Source: org_study_id