Clinical trial NCT06906198: Pharmacokinetics of VVN461 Ophthalmic Solution
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: VivaVision Biotech, Inc
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dose-escalating
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety outcome
timeFrame: Baseline to Day 16
Secondary outcomes:
measure: Time to maximum blood level
timeFrame: Maximum seen over Days 1 to 9
measure: Area under the curve of blood levels until last observation
timeFrame: Integrated over Days 1 to 9
measure: Area under the curve of blood levels extrapolated to infinity
timeFrame: Integrated over Days 1 to 9
measure: Half life of drug in blood
timeFrame: Integrated over Days 1 to 9
Other outcomes:
measure: Maximum concentration of drug in blood
timeFrame: Integrated over Days 1 to 9
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: