Healthy VolunteersPhase 1NCT06906198
Pharmacokinetics of VVN461 Ophthalmic Solution
A Phase 1 study testing VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and VVN461 Ophthalmic Solution 0.25% in people with Healthy Volunteers, run by VivaVision Biotech, Inc at 1 site in China.
Trial summary
This is a single-center, double-masked, randomized, vehicle-controlled study conducted in China in adult healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and VVN461 Ophthalmic Solution 0.25%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 22 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
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
This is a single-center, double-masked, randomized, vehicle-controlled study conducted in China in adult healthy subjects
Read the 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
- Being tested
- VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5%, VVN461 Ophthalmic Solution 0.25%, VVN461 Ophthalmic Solution Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVN461 Ophthalmic Solution 1.0%Drug
VVN461, 1.0%
VVN461 Ophthalmic Solution 0.5%Drug
VVN461, 0.5%
VVN461 Ophthalmic Solution 0.25%Drug
VVN461, 0.25%
VVN461 Ophthalmic Solution PlaceboDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| VVN461, 1.0% | Experimental | VVN461 Ophthalmic Solution, 1.0% Receives: Drug: VVN461 Ophthalmic Solution 1.0% |
| VVN461, 0.5% | Experimental | VVN461 Ophthalmic Solution, 0.5% Receives: Drug: VVN461 Ophthalmic Solution 0.5% |
| VVN461, 0.25% | Experimental | VVN461 Ophthalmic Solution, 0.25% Receives: Drug: VVN461 Ophthalmic Solution 0.25% |
| Vehicle | Placebo comparator | VVN461 Ophthalmic Solution, Placebo Receives: Drug: VVN461 Ophthalmic Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
Incidence of adverse events
Measured: Baseline to Day 16
Secondary outcomes (4)
Time to maximum blood level
Tmax
Measured: Maximum seen over Days 1 to 9
Area under the curve of blood levels until last observation
AUC0-last
Measured: Integrated over Days 1 to 9
Area under the curve of blood levels extrapolated to infinity
AUC0-inf
Measured: Integrated over Days 1 to 9
Half life of drug in blood
t1/2
Measured: Integrated over Days 1 to 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Mar 2023
- Primary completion10 May 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dose-escalating
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VivaVision Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906198
- Sponsor's protocol ID
- VVN461-CCS-101
- Status last verified
- Mar 2025
- First submitted
- 3 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06906198
- Acronym / sponsor ID
- VVN461-CCS-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- dose-escalating
| Arm | Type | Receives |
|---|---|---|
| VVN461, 1.0% | Experimental | Drug: VVN461 Ophthalmic Solution 1.0%VVN461 Ophthalmic Solution, 1.0% |
| VVN461, 0.5% | Experimental | Drug: VVN461 Ophthalmic Solution 0.5%VVN461 Ophthalmic Solution, 0.5% |
| VVN461, 0.25% | Experimental | Drug: VVN461 Ophthalmic Solution 0.25%VVN461 Ophthalmic Solution, 0.25% |
| Vehicle | Placebo comparator | Drug: VVN461 Ophthalmic Solution PlaceboVVN461 Ophthalmic Solution, Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVN461 Ophthalmic Solution 1.0%VVN461, 1.0% | Drug | VVN461, 1.0% |
| VVN461 Ophthalmic Solution 0.5%VVN461, 0.5% | Drug | VVN461, 0.5% |
| VVN461 Ophthalmic Solution 0.25%VVN461, 0.25% | Drug | VVN461, 0.25% |
| VVN461 Ophthalmic Solution PlaceboVehicle | Drug | Vehicle |
Primary outcome
Safety outcome
Time frame: Baseline to Day 16
Incidence of adverse events
4 secondary outcomes
Time to maximum blood level
Time frame: Maximum seen over Days 1 to 9
Area under the curve of blood levels until last observation
Time frame: Integrated over Days 1 to 9
Area under the curve of blood levels extrapolated to infinity
Time frame: Integrated over Days 1 to 9
Half life of drug in blood
Time frame: Integrated over Days 1 to 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and VVN461 Ophthalmic Solution 0.25% in people with Healthy Volunteers, run by VivaVision Biotech, Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: Baseline to Day 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.