A Phase 1 interventional study of G01 Eye Drops 100 µg/mL SAD and G01 Eye Drops 200 µg/mL SAD in Healhty, sponsored by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. · Phase 1, Interventional, and Basic science
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.
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.
Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Drug: Placebo of G01 Eye Drops SAD · Drug: Placebo of G01 Eye Drops MAD
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
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
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
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.
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.
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.
All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list
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.
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).
Time frame: 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
Time frame: From baseline through post-study visit, up to Day 14 for single-administration cohorts and multiple-administration cohorts
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.
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)
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.
Time frame: Day 1, Day 3, Day 14 for single-administration cohorts; Day 1, Day 8, Day 14 for multiple-administration cohorts
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.