Pharmacokinetics of VVN461 Ophthalmic Solution

NCT06906198 | Completed Phase 1

• 1 other identifier: VVN461-CCS-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety outcome

  Incidence of adverse events

  Baseline to Day 16

Secondary Outcomes (4)

• Time to maximum blood level

  Maximum seen over Days 1 to 9

• Area under the curve of blood levels until last observation

  Integrated over Days 1 to 9

• Area under the curve of blood levels extrapolated to infinity

  Integrated over Days 1 to 9

• Half life of drug in blood

  Integrated over Days 1 to 9

Other Outcomes (1)

• Maximum concentration of drug in blood

  Integrated over Days 1 to 9

Study Arms (4)

VVN461, 1.0%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 1.0%

Drug: VVN461 Ophthalmic Solution 1.0%

VVN461, 0.5%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 0.5%

Drug: VVN461 Ophthalmic Solution 0.5%

VVN461, 0.25%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 0.25%

Drug: VVN461 Ophthalmic Solution 0.25%

Vehicle

PLACEBO COMPARATOR

VVN461 Ophthalmic Solution, Placebo

Drug: VVN461 Ophthalmic Solution Placebo

Interventions

VVN461 Ophthalmic Solution 1.0% DRUG

VVN461, 1.0%

VVN461, 1.0%

VVN461 Ophthalmic Solution 0.5% DRUG

VVN461, 0.5%

VVN461, 0.5%

VVN461 Ophthalmic Solution 0.25% DRUG

VVN461, 0.25%

VVN461, 0.25%

VVN461 Ophthalmic Solution Placebo DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: dose-escalating

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: April 2, 2025
• Study Start: March 1, 2023
• Primary Completion: May 10, 2023
• Study Completion: December 22, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)