HealhtyPhase 1NCT07779902
Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers
A Phase 1 study testing G01 Eye Drops 100 µg/mL SAD, G01 Eye Drops 200 µg/mL SAD and G01 Eye Drops 400 µg/mL SAD in people with Healhty, run by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in 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
- Healhty
- What is being tested?
- G01 Eye Drops 100 µg/mL SAD, G01 Eye Drops 200 µg/mL SAD and G01 Eye Drops 400 µg/mL SAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 28 Jun 2025
- 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
- Healthy adults aged 18 to 50 years (inclusive) at the time of signing the informed consent form, of either sex.
- Body weight ≥50 kg for males and ≥45 kg for females at screening; body mass index (BMI) within the range of 19.0 to 28.0 kg/m² (inclusive), calculated as body weight (kg) / height² (m²); vital signs, laboratory tests, and physical examination findings are either within normal limits or deemed clinically insignificant (abnormal without clinical relevance).
- Best-corrected visual acuity (BCVA) ≥83 letters in both eyes (with refractive error ≤ -6.0 D); intraocular pressure (IOP) between 10 and 21 mmHg (inclusive) in both eyes, with an interocular IOP difference <5 mmHg; ophthalmic examinations in both eyes (including BCVA, IOP, pupillary function, extraocular muscle motility, slit-lamp biomicroscopy, corneal fluorescein staining, and funduscopy after mydriasis) show no abnormalities, or any abnormalities present are clinically insignificant.
- Ability and willingness to provide written informed consent, dated and signed personally, and to comprehend the study procedures and comply with all protocol requirements.
- Agreement to practice effective contraception from the time of signing informed consent through 3 months after the last dose of study drug, and no plan to donate sperm or ova during this period.
Who cannot join
- Women who are pregnant or lactating.
- History or presence of severe disorders of the cardiovascular, respiratory, hepatobiliary, digestive, urinary, renal, endocrine, immune, metabolic, or neuropsychiatric systems, or history of malignancy.
- Anatomical abnormality in either eye or monocular vision; or any eyelid, ocular surface, or lacrimal drainage system abnormality deemed by the investigator to potentially affect drug absorption.
- History of ocular disease in either eye that could affect visual function (e.g., glaucoma, retinal detachment, etc.), and considered by the investigator as unsuitable for trial participation.
- Infectious, immune-mediated, or inflammatory ocular disease, or ocular trauma affecting either eye within 3 months prior to the first dose.
- Clinically significant findings on ophthalmic examination at screening (e.g., conjunctival hyperemia grade ≥1, >2 punctate corneal fluorescein staining spots, tear film break-up time [TBUT] <10 seconds in both eyes, or other chronic or acute ocular pathologies).
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- History of intraocular surgery or ocular laser therapy.
- Use of any ophthalmic medication (including eye drops or ophthalmic gels, etc.) within 1 month prior to screening.
- Contact lens wear within 14 days prior to screening or during the clinical study period.
- Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody/antigen, or syphilis serology.
- History of drug allergy, particularly known allergy or idiosyncratic reaction to the investigational product or to any concomitant medications used during the study procedures.
- Inability to tolerate venipuncture and/or history of vasovagal syncope (hemophobia or trypanophobia).
- Prior treatment with any other nerve growth factor (NGF)-class agents; use of immunosuppressants or any other prescription medications within 4 weeks prior to the start of the study; use of traditional Chinese medicines, Chinese patent medicines, over-the-counter drugs, or dietary supplements within 2 weeks prior to the start of the study. (For drugs with a long half-life, a washout period of at least 5 half-lives is required.)
- Participation in any other interventional clinical trial within 3 months prior to screening.
- Vaccination within 1 month prior to screening, or planned vaccination during the study period.
- Major surgery within 6 months prior to screening, or planned surgery during the study period.
- History of drug abuse, positive urine drug screen, or current substance dependence.
- Non-physiological blood loss ≥400 mL (including trauma, phlebotomy, or blood donation) within 3 months prior to the study, or receipt of any blood product transfusion; or blood donation within 3 months or planned blood donation during the study period; or blood sampling as a subject in another study within 3 months.
- Average daily cigarette consumption >5 cigarettes per day within 3 months prior to screening, or inability to refrain from smoking throughout the entire study period.
- Suspected or confirmed alcohol dependence; average daily alcohol intake exceeding 2 units per day within 3 months (1 unit = 10 mL of pure ethanol, equivalent to 200 mL of beer at 5% alcohol, 25 mL of spirits at 40% alcohol, or 83 mL of wine at 12% alcohol); or positive alcohol breath test; or inability to abstain from alcohol during the study period.
- Vital signs outside the following ranges: systolic blood pressure <90 mmHg or ≥140 mmHg; diastolic blood pressure <50 mmHg or ≥90 mmHg; pulse rate <50 bpm or >100 bpm.
- Any other condition that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Single-center, Randomized, Double-masked, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of G01 Eye Drops Following Single and Multiple Administrations in Healthy Subjects.
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in healthy subjects.
Read the detailed description
This is a Phase I, randomised, double-masked, placebo-controlled study of G01 Eye Drops in healthy male and female subjects.
This study comprises a single ascending dose part (single ocular application of two drop) and a multiple ascending dose part (two drop three times daily for seven consecutive days). Three ascending dose levels will be included in both parts. In both the single and multiple ascending dose parts, each ascending cohort will enroll 6 subjects receiving G01 Eye Drops and 2 subjects receiving placebo.
- Conditions
- Healhty
- Being tested
- G01 Eye Drops 100 µg/mL SAD, G01 Eye Drops 200 µg/mL SAD, G01 Eye Drops 400 µg/mL SAD, G01 Eye Drops 100 µg/mL MAD, G01 Eye Drops 200 µg/mL MAD
- Keywords
- G01 Eye Drops, phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G01 Eye Drops 100 µg/mL SADDrug
all subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
G01 Eye Drops 200 µg/mL SADDrug
All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
G01 Eye Drops 400 µg/mL SADDrug
All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level
G01 Eye Drops 100 µg/mL MADDrug
All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
G01 Eye Drops 200 µg/mL MADDrug
All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
G01 Eye Drops 400 µg/mL MADDrug
All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
Placebo of G01 Eye Drops SADDrug
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list
Placebo of G01 Eye Drops MADDrug
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list , which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.
| Study group | Role | What they receive |
|---|---|---|
| G01 Eye Drops | Experimental | Subjects receive topical ocular administration of G01 Eye Drops in a dose-escalation design with three predefined concentration levels (100 µg/mL, 200 µg/mL, and 400 µg/mL), including single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. SAD regimen: A single topical instillation of 2 drops (33 μL per drop) of the assigned concentration is administered to the right eye on the morning of Day 1. MAD regimen: 2 drops (33 μL per drop) of the assigned concentration are topically administered to the right eye three times daily (morning, midday, and bedtime) for 6 consecutive days from Day 1 to Day 6; only one single morning instillation is performed on Day 7 Receives: Drug: G01 Eye Drops 100 µg/mL SAD; Drug: G01 Eye Drops 200 µg/mL SAD; Drug: G01 Eye Drops 400 µg/mL SAD; Drug: G01 Eye Drops 100 µg/mL MAD; Drug: G01 Eye Drops 200 µg/mL MAD; Drug: G01 Eye Drops 400 µg/mL MAD |
| Placebo of G01 Eye Drops | Placebo comparator | Subjects receive Placebo of G01 Eye Drops for ocular topical administration, matching the three escalating concentration groups (100 µg/mL, 200 µg/mL, 400 µg/mL) of the investigational drug. The administration regimen is identical to the treatment group. Single-dose regimen: 2 drops (33 μL/drop) instilled into the right eye once on the morning of Day 1. Multiple-dose regimen: 2 drops (33 μL/drop) administered three times daily (morning, noon, bedtime) to the right eye for 6 consecutive days (Day 1 to Day 6); only one morning administration of 2 drops (33 μL/drop) is performed on Day 7. Receives: Drug: Placebo of G01 Eye Drops SAD; Drug: Placebo of G01 Eye Drops MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be evaluated for seriousness, severity, relationship to study drug, action taken, outcome, and classification as treatment-emergent adverse events (TEAEs).
Measured: From informed consent through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Safety assessments include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. The number and percentage of participants with clinically significant abnormali
Measured: From baseline through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
Secondary outcomes (2)
Serum Concentration of G01 Eye Drops
Serum drug concentrations of G01 Eye Drops will be measured and analyzed to characterize the serum concentration profiles in single-administration and multiple-administration cohorts. Blood samples for concentration analysis will be collected at scheduled time points throughout the study period. The scheduled sampling time points may be adjusted appropriately according to the actual detection results during the study.
Measured: Day 1, Day 2, Day 3 for single-administration cohorts; Day 1, Day 5, Day 6, Day 7, Day 8, Day 9 for multiple-administration cohorts
Number of Participants With Positive Anti-Drug Antibody (ADA)
Blood samples will be collected at scheduled time points to detect anti-drug antibody (ADA) against G01 Eye Drops. The number and percentage of participants with positive ADA results will be summarized in single-administration and multiple-administration cohorts to evaluate the immunogenicity of G01 Eye Drops.
Measured: Day 1, Day 3, Day 14 for single-administration cohorts; Day 1, Day 8, Day 14 for multiple-administration cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start12 Dec 2024
- Primary completion28 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealhtyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, sequential dose-escalation study consisting of single ascending dose (SAD) and multiple ascending dose (MAD) parts. Eligible healthy subjects are enrolled in sequential dose cohorts with fixed drug-placebo allocation ratio to evaluate safety, tolerability and pharmacokinetics of G01 Eye Drops.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuzhong Wang, Principal investigator, Affiliated Hospital of Jining Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779902
- Sponsor's protocol ID
- WM-G01-I
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beykin G, Stell L, Halim MS, Nunez M, Popova L, Nguyen BT, Groth SL, Dennis A, Li Z, Atkins M, Khavari T, Wang SY, Chang R, Fisher AC, Sepah YJ, Goldberg JL. Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes. Am J Ophthalmol. 2022 Feb;234:223-234. doi: 10.1016/j.ajo.2021.11.002. Epub 2021 Nov 13.
PubMed 34780798Ferrari MP, Mantelli F, Sacchetti M, Antonangeli MI, Cattani F, D'Anniballe G, Sinigaglia F, Ruffini PA, Lambiase A. Safety and pharmacokinetics of escalating doses of human recombinant nerve growth factor eye drops in a double-masked, randomized clinical trial. BioDrugs. 2014 Jun;28(3):275-83. doi: 10.1007/s40259-013-0079-5.
PubMed 24327173
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Single-center, Randomized, Double-masked, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of G01 Eye Drops Following Single and Multiple Administrations in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT07779902
- Acronym / sponsor ID
- WM-G01-I
- Conditions
- Healhty
- Keywords
- G01 Eye Drops, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 21 Aug 2026 (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.
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in healthy subjects.
Detailed description
This is a Phase I, randomised, double-masked, placebo-controlled study of G01 Eye Drops in healthy male and female subjects.
This study comprises a single ascending dose part (single ocular application of two drop) and a multiple ascending dose part (two drop three times daily for seven consecutive days). Three ascending dose levels will be included in both parts. In both the single and multiple ascending dose parts, each ascending cohort will enroll 6 subjects receiving G01 Eye Drops and 2 subjects receiving placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, sequential dose-escalation study consisting of single ascending dose (SAD) and multiple ascending dose (MAD) parts. Eligible healthy subjects are enrolled in sequential dose cohorts with fixed drug-placebo allocation ratio to evaluate safety, tolerability and pharmacokinetics of G01 Eye Drops.
| Arm | Type | Receives |
|---|---|---|
| G01 Eye Drops | Experimental | Drug: G01 Eye Drops 100 µg/mL SAD, Drug: G01 Eye Drops 200 µg/mL SAD, Drug: G01 Eye Drops 400 µg/mL SAD, Drug: G01 Eye Drops 100 µg/mL MAD, Drug: G01 Eye Drops 200 µg/mL MAD, Drug: G01 Eye Drops 400 µg/mL MADSubjects receive topical ocular administration of G01 Eye Drops in a dose-escalation design with three predefined concentration levels (100 µg/mL, 200 µg/mL, and 400 µg/mL), including single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. SAD regimen: A single topical instillation of 2 drops (33 μL per drop) of the assigned concentration is administered to the right eye on the morning of Day 1. MAD regimen: 2 drops (33 μL per drop) of the assigned concentration are topically administered to the right eye three times daily (morning, midday, and bedtime) for 6 consecutive days from Day 1 to Day 6; only one single morning instillation is performed on Day 7 |
| Placebo of G01 Eye Drops | Placebo comparator | Drug: Placebo of G01 Eye Drops SAD, Drug: Placebo of G01 Eye Drops MADSubjects receive Placebo of G01 Eye Drops for ocular topical administration, matching the three escalating concentration groups (100 µg/mL, 200 µg/mL, 400 µg/mL) of the investigational drug. The administration regimen is identical to the treatment group. Single-dose regimen: 2 drops (33 μL/drop) instilled into the right eye once on the morning of Day 1. Multiple-dose regimen: 2 drops (33 μL/drop) administered three times daily (morning, noon, bedtime) to the right eye for 6 consecutive days (Day 1 to Day 6); only one morning administration of 2 drops (33 μL/drop) is performed on Day 7. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged 18 to 50 years (inclusive) at the time of signing the informed consent form, of either sex.
- Body weight ≥50 kg for males and ≥45 kg for females at screening; body mass index (BMI) within the range of 19.0 to 28.0 kg/m² (inclusive), calculated as body weight (kg) / height² (m²); vital signs, laboratory tests, and physical examination findings are either within normal limits or deemed clinically insignificant (abnormal without clinical relevance).
- Best-corrected visual acuity (BCVA) ≥83 letters in both eyes (with refractive error ≤ -6.0 D); intraocular pressure (IOP) between 10 and 21 mmHg (inclusive) in both eyes, with an interocular IOP difference <5 mmHg; ophthalmic examinations in both eyes (including BCVA, IOP, pupillary function, extraocular muscle motility, slit-lamp biomicroscopy, corneal fluorescein staining, and funduscopy after mydriasis) show no abnormalities, or any abnormalities present are clinically insignificant.
- Ability and willingness to provide written informed consent, dated and signed personally, and to comprehend the study procedures and comply with all protocol requirements.
- Agreement to practice effective contraception from the time of signing informed consent through 3 months after the last dose of study drug, and no plan to donate sperm or ova during this period.
Key exclusion criteria (22 listed)
- Women who are pregnant or lactating.
- History or presence of severe disorders of the cardiovascular, respiratory, hepatobiliary, digestive, urinary, renal, endocrine, immune, metabolic, or neuropsychiatric systems, or history of malignancy.
- Anatomical abnormality in either eye or monocular vision; or any eyelid, ocular surface, or lacrimal drainage system abnormality deemed by the investigator to potentially affect drug absorption.
- History of ocular disease in either eye that could affect visual function (e.g., glaucoma, retinal detachment, etc.), and considered by the investigator as unsuitable for trial participation.
- Infectious, immune-mediated, or inflammatory ocular disease, or ocular trauma affecting either eye within 3 months prior to the first dose.
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 |
|---|---|---|
| G01 Eye Drops 100 µg/mL SADall subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level | Drug | G01 Eye Drops |
| G01 Eye Drops 200 µg/mL SADAll subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level | Drug | G01 Eye Drops |
| G01 Eye Drops 400 µg/mL SADAll subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level | Drug | G01 Eye Drops |
| G01 Eye Drops 100 µg/mL MADAll subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7. | Drug | G01 Eye Drops |
| G01 Eye Drops 200 µg/mL MADAll subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7. | Drug | G01 Eye Drops |
| G01 Eye Drops 400 µg/mL MADAll subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7. | Drug | G01 Eye Drops |
| Placebo of G01 Eye Drops SADAll subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list | Drug | Placebo of G01 Eye Drops |
| Placebo of G01 Eye Drops MADAll subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list , which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7. | Drug | Placebo of G01 Eye Drops |
Primary outcome
Number of Participants With Adverse Events
Time frame: From informed consent through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be evaluated for seriousness, severity, relationship to study drug, action taken, outcome, and classification as treatment-emergent adverse events (TEAEs).
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Time frame: From baseline through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
Safety assessments include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. The number and percentage of participants with clinically significant abnormali
2 secondary outcomes
Serum Concentration of G01 Eye Drops
Time frame: Day 1, Day 2, Day 3 for single-administration cohorts; Day 1, Day 5, Day 6, Day 7, Day 8, Day 9 for multiple-administration cohorts
Number of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Day 1, Day 3, Day 14 for single-administration cohorts; Day 1, Day 8, Day 14 for multiple-administration cohorts
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 21 Aug 2026.
- Background: PubMed 34780798Beykin G, Stell L, Halim MS, Nunez M, Popova L, Nguyen BT, Groth SL, Dennis A, Li Z, Atkins M, Khavari T, Wang SY, Chang R, Fisher AC, Sepah YJ, Goldberg JL. Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes. Am J Ophthalmol. 2022 Feb;234:223-234. doi: 10.1016/j.ajo.2021.11.002. Epub 2021 Nov 13.
- Background: PubMed 24327173Ferrari MP, Mantelli F, Sacchetti M, Antonangeli MI, Cattani F, D'Anniballe G, Sinigaglia F, Ruffini PA, Lambiase A. Safety and pharmacokinetics of escalating doses of human recombinant nerve growth factor eye drops in a double-masked, randomized clinical trial. BioDrugs. 2014 Jun;28(3):275-83. doi: 10.1007/s40259-013-0079-5.
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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.
Yuzhong Wang principal investigator
Affiliated Hospital of Jining Medical University
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 G01 Eye Drops 100 µg/mL SAD, G01 Eye Drops 200 µg/mL SAD and G01 Eye Drops 400 µg/mL SAD in people with Healhty, run by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. 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 22 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 21 Aug 2026. 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?
Number of Participants With Adverse Events (time frame: From informed consent through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07779902, which also lists 2 linked publications.
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 21 Aug 2026.