A Phase 1 interventional study of PAN-90806 Ophthalmic Solution and Vehicle Ophthalmic Solution in Wet Age Related Macular Degeneration and Neovascular (Wet) Age-Related Macular Degeneration, sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (formerly part of Lee's Pharmaceutical Limited) · Phase 1, Interventional, and Health services research
The goal of this clinical trial is to learn about the safety, tolerability, and systemic pharmacokinetics of PAN-90806 eye drops in healthy adults. It will also evaluate what medical problems participants may have when taking PAN-90806. The main questions it aims to answer are:
Is PAN-90806 eye drops safe and well tolerated in healthy participants? What are the systemic pharmacokinetic characteristics of PAN-90806 after ocular administration? What medical problems or adverse events do participants have when taking PAN-90806? Researchers will compare PAN-90806 eye drops to a placebo (a look-alike eye drop that contains no PAN-90806) to evaluate the safety, tolerability, and systemic pharmacokinetics of PAN-90806.
Participants will:
Receive PAN-90806 eye drops or placebo eye drops once daily in both eyes, one drop per eye, on Day 1 and Days 3 to 7, for a total of 6 dosing days Stay at the study center during the inpatient dosing period and attend scheduled study visits for screening, admission, dosing, and discharge Undergo blood sampling for pharmacokinetic testing, as well as eye examinations, laboratory tests, vital signs assessments, physical examinations, and ECGs
The goal of this Phase Ia clinical trial is to evaluate the safety, tolerability, and systemic pharmacokinetics of PAN-90806 eye drops in healthy adult volunteers. The study is designed to determine whether PAN-90806 eye drops can be administered safely in healthy participants and to describe how the drug is absorbed into the bloodstream after repeated ocular dosing. It will also assess what adverse events or other medical problems may occur during treatment.
The main questions this study aims to answer are:
Is PAN-90806 eye drops safe and well tolerated in healthy adult participants? What systemic pharmacokinetic characteristics does PAN-90806 show after administration as an eye drop? What eye-related or systemic adverse events occur during treatment with PAN-90806? Researchers will compare PAN-90806 eye drops with a placebo eye drop formulation that does not contain PAN-90806 but is otherwise identical in composition. This comparison will help evaluate the safety, tolerability, and systemic exposure profile of PAN-90806 under controlled conditions.
This is a randomized, double-blind, placebo-controlled, single-center Phase Ia study. A total of 20 healthy volunteers are planned for enrollment, with participants randomized in a 3:1 ratio to receive either PAN-90806 eye drops (10 mg/mL, 1.0%) or placebo eye drops. Both male and female participants may be enrolled. The study includes 4 visits: a screening visit from Day -14 to Day -1, an admission visit on Day 0, an inpatient dosing period from Day 1 to Day 8, and a discharge visit on Day 9. The total study duration for each participant is approximately 11 to 24 days.
Participants will:
Receive PAN-90806 eye drops or placebo eye drops once daily in both eyes, with 1 drop per eye, on Day 1 and on Days 3 through 7, for a total of 6 dosing days Be admitted to the clinical research unit and remain under inpatient observation during the treatment period Have all doses administered by study staff; self-administration will not be allowed Use single-dose preservative-free study medication containers, which will be discarded immediately after use Follow study restrictions during inpatient stay, including controlled meals, no smoking, no alcohol, no nicotine-containing products, no caffeine-containing foods or drinks, and no strenuous exercise Undergo intensive blood sampling for systemic pharmacokinetic assessment, with a total of 31 blood collection time points and approximately 155 mL of blood collected Complete ophthalmic and general safety assessments, including corneal endothelial cell examination, central corneal thickness, fluorescein corneal staining, lissamine green conjunctival staining, best corrected visual acuity, intraocular pressure, slit-lamp biomicroscopy, non-mydriatic fundus photography, laboratory tests, vital signs, physical examinations, ECGs, and adverse event monitoring The pharmacokinetic endpoints include Tmax, Cmax, AUC0-t, t1/2, Cmax,ss, AUCss, CL or CL/F, and DF. Safety and tolerability will be assessed through ocular examinations, laboratory evaluations, vital signs, ECGs, physical examinations, and the incidence and severity of ocular and systemic adverse events, including events of special interest.
Eligible participants must be healthy adults 18 to 50 years of age who meet specified body weight, BMI, ocular health, and general health requirements. Participants with clinically significant eye disease, recent surgery, relevant medical conditions, recent medication use, positive infectious disease screening, substance abuse, or other factors that may interfere with study safety or pharmacokinetic evaluation will be excluded.
Overall, this study is intended to provide an early clinical assessment of PAN-90806 eye drops in healthy volunteers by characterizing their safety profile and systemic pharmacokinetics after repeated bilateral ocular dosing under closely monitored inpatient conditions.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 20 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
First submitted after Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. left Lee's Pharmaceutical Limited.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
Drug: PAN-90806 Ophthalmic Solution
Drug: Vehicle Ophthalmic Solution
The medication was administered at 9:00am every morning on Day 1 and Day 3-Day 7 of hospitalization. Each time, the medication is administered to both eyes, 1 drop per eye, for a total of 6 days of treatment.
The medication was administered at 9:00am every morning on Day 1 and Day 3-Day 7 of hospitalization. Each time, the medication is administered to both eyes, 1 drop per eye, for a total of 6 days of treatment.
Corneal endothelial cell examination (density(cells/mm2)
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Corneal endothelial cell examination (coefficient of variation(% of variation in total endothelial cell size ))
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Corneal endothelial cell examination(proportion of hexagonal cells(%))
Using Corneal endothelial cell analyzer for the Corneal endothelial cell examination
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Central corneal thickness (μm)
Central corneal thickness measurement;
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
sodium fluorescein staining score of the cornea (NEI scale for the score)
Time frame: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
Conjunctival lissamine green staining score of the cornea (NEI scale for the score)
Time frame: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9(set Day 0 as the day hospitalized)
Best corrected visual acuity(National standard logarithmic eye chart of China)
Time frame: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
intraocular pressure measurements(mmHg)
Non-contact tonometer or rebound tonometer for the measurements
Time frame: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
slit-lamp biomicroscopy
The eyelids, conjunctiva, cornea, iris, anterior chamber, lens and other parts were observed through the slit lamp, and the researchers Determine whether the test results are abnormal and have clinical significance
Time frame: Day-14~Day -1, Day 2, Day 4, Day 6 and Day 9 (set Day 0 as the day hospitalized)
non-dilated retinal photography
Use a non-mydriatic wide-angle fundus camera. No need to dilate your pupils. Follow the instructions for taking pictures.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
The incidence of adverse events
Adverse events are coded using the Chinese version of MedDRA 29.0 and above. Adverse events (TEAEs) and adverse reactions that occurred during treatment were summarized according to system organ classification (SOC) and preferred term (PT), and the number, occurrence and percentage of all volunteers who experienced TEAEs and adverse reactions were counted.
Time frame: Day 1~Day 9
The severity of adverse events
The severity of adverse events is divided into three levels: mild, moderate and severe.
Time frame: Day 1~Day 9
blood pressure (using the portable blood pressure monitor, mmHg)
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Pulse (using the portable blood pressure monitor, beats per minute (BPM))
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Body temperature (Body temperature detection using infrared ear thermometer, ℃)
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
physical examination
Physical examination, including skin, lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system and others. The researcher will judge whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
electrocardiogra (Heart rate, PR interval(ms), QRS time limit(ms), QT/QTc interval(ms))
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
electrocardiogra (Heart rate)
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
electrocardiogra (PR interval(ms))
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
electrocardiogra (QT/QTc interval(ms))
The researcher will determine whether the test results are abnormal and have clinical significance.
Time frame: Day-14~Day -1, and Day 9 (set Day 0 as the day hospitalized)
Pharmacokinetic parameters
Tmax: Time to Maximum Observed Concentration(hour)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Cmax: Maximum Observed Concentration(ng/mL)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
AUC0-t: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Time Point
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
t1/2: Terminal Elimination Half-Life(hour)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
Cmax,ss: Maximum Observed Concentration at Steady State(ng/mL)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
AUCss: Area Under the Concentration-Time Curve at Steady State CL: Clearance
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
CL: Clearance(mL/min)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
CL/F: Apparent Clearance (Clearance after Extravascular Administration, adjusted for Bioavailability) (mL/min)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
Pharmacokinetic parameters
DF: Degree of Fluctuation(%)
Time frame: Day 1, day 3, day 4, day 5, day 6, day7
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 60 industry-sponsored phase 1 interventional studies under Macular Degeneration, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 3 months is below that.
Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cp-547632
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. →