PharmacokineticsPhase 1NCT05855018
A Study of Atropine Sulfate in Healthy Chinese Volunteers
A Phase 1 study testing Atropine sulfate eye drops in people with Pharmacokinetics, run by Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited at 1 site in China.
Trial summary
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Atropine sulfate eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18-45 (including cut-off value) at screening;
- Subject with a body mass index (BMI) between 19.0-26.0kg/m2 (including cut-off value), male weight ≥50.0kg, female weight ≥45.0kg at screening and D0;
- Subject is in good health, as determined by the investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening and D0;
Who cannot join
- Subject with any eye with corrected visual acuity <1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination.
- Subject with history of eye diseases, including the history of internal eye surgery or laser surgery.
- Subject with clinically significant history of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic, and musculoskeletal system diseases etc., which may endanger the safety of the subject or affect the results of the study, as judged by the investigator.
- Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops.
- On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months.
- Subject has used any topical or systemic antimuscarinic/anticholinergic drugs (e.g., atropine, 1-hyoscyamine, tropicamide, chlorpheniramine, diphenhydramine, oxytropine, cyclic antidepressants, etc.) within 3 weeks before screening.
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- Subject has used any local or systemic drugs (including any prescription or over-the-counter drugs) within 2 weeks before screening.
- Subject has participated in interventional clinical trials within 3 months before screening.
- Subject who has worn contact lenses or cosmetic contact lenses within 1 weeks before screening.
- Subject who is pregnant or breastfeeding.
- The investigator believes that the subject is not suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
HKU Eye Centre
Hong Kong
Christopher LEUNG, +852 25181430, cleung21@hku.hk
About this study
Official title: A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
Read the detailed description
This is a randomized, open-label, phase I clinical study evaluating the systemic pharmacokinetics and safety of atropine sulfate eye drops in healthy Chinese volunteers.Three concentrations will be investigated, each concentration group must contain both male and female subjects, and each subject receives only one concentration of atropine sulfate eye drop in this study.
The three treatment arms are:
Atropine sulfate dose A (low concentration)
Atropine sulfate dose B (medium concentration)
Atropine sulfate dose C (high concentration)
- Conditions
- Pharmacokinetics
- Being tested
- Atropine sulfate eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulfate eye dropsDrug
Also called Atropine sulfate
One drop once daily
| Study group | Role | What they receive |
|---|---|---|
| Atropine sulfate Concentration A | Experimental | Subjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD). Receives: Drug: Atropine sulfate eye drops |
| Atropine sulfate Concentration B | Experimental | Subjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD). Receives: Drug: Atropine sulfate eye drops |
| Atropine sulfate Concentration C | Experimental | Subjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD). Receives: Drug: Atropine sulfate eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Time of Cmax (Tmax)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Time of half-life (t1/2)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to last draw time (AUC0-t)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞))
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Minimum concentration (Cmin)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Volume of distribution (Vd)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Elimination rate constant (Kel)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Clearance (CL)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Apparent Clearance (CL/F)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Measured: From 1 hour before administration to 24 hours after administration
Secondary outcomes (6)
Slit-lamp eye examination results change from baseline to Day 7
Evaluate the anterior segment of the eye, including the eyelids, cornea, conjunctiva, anterior chamber, iris and lens, and record abnormalities
Measured: on Day 0 and Day 7
Fundoscopy eye examination results change from baseline to Day 7
Evaluate the condition of the fundus, including the vitreous body, optic disc, macula, peripheral retina and retinal blood vessels
Measured: on Day 0 and Day 7
Intraocular pressure change from baseline to Day 7
Use non-contact tonometer to measure intraocular pressure
Measured: on Day 0 and Day 7
Vision acuity change from baseline to Day 7
Using Best-corrected LogMAR scale
Measured: on Day 0 and Day 7
The mean change of pupil diameter from baseline to Day 7
Use ophthalmic biometry equipment to measure pupil diameter
Measured: on Day 0 and Day 7
The mean change of accommodation amplitude from baseline to Day 7
Use a Phoropter to measure the accommodation amplitude using the negative lens method
Measured: on Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start9 May 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher LEUNG, Principal investigator, HKU Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855018
- Sponsor's protocol ID
- ZKO(HK)-ATP-202111
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT05855018
- Acronym / sponsor ID
- ZKO(HK)-ATP-202111
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhaoke (Hong Kong) Ophthalmology Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 May 2023 (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.
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
Detailed description
This is a randomized, open-label, phase I clinical study evaluating the systemic pharmacokinetics and safety of atropine sulfate eye drops in healthy Chinese volunteers.Three concentrations will be investigated, each concentration group must contain both male and female subjects, and each subject receives only one concentration of atropine sulfate eye drop in this study.
The three treatment arms are:
Atropine sulfate dose A (low concentration)
Atropine sulfate dose B (medium concentration)
Atropine sulfate dose C (high concentration)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atropine sulfate Concentration A | Experimental | Drug: Atropine sulfate eye dropsSubjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD). |
| Atropine sulfate Concentration B | Experimental | Drug: Atropine sulfate eye dropsSubjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD). |
| Atropine sulfate Concentration C | Experimental | Drug: Atropine sulfate eye dropsSubjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18-45 (including cut-off value) at screening;
- Subject with a body mass index (BMI) between 19.0-26.0kg/m2 (including cut-off value), male weight ≥50.0kg, female weight ≥45.0kg at screening and D0;
- Subject is in good health, as determined by the investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening and D0;
Key exclusion criteria (11 listed)
- Subject with any eye with corrected visual acuity <1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination.
- Subject with history of eye diseases, including the history of internal eye surgery or laser surgery.
- Subject with clinically significant history of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic, and musculoskeletal system diseases etc., which may endanger the safety of the subject or affect the results of the study, as judged by the investigator.
- Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops.
- On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months.
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 |
|---|---|---|
| Atropine sulfate eye dropsAlso: Atropine sulfateOne drop once daily | Drug | Atropine sulfate Concentration A, Atropine sulfate Concentration B, Atropine sulfate Concentration C |
Primary outcome
Maximum concentration (Cmax)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time of Cmax (Tmax)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time of half-life (t1/2)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Area Under time-concentration Curve from 0 to last draw time (AUC0-t)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞))
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Minimum concentration (Cmin)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Volume of distribution (Vd)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Elimination rate constant (Kel)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Clearance (CL)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Apparent Clearance (CL/F)
Time frame: From 1 hour before administration to 24 hours after administration
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
6 secondary outcomes
Slit-lamp eye examination results change from baseline to Day 7
Time frame: on Day 0 and Day 7
Fundoscopy eye examination results change from baseline to Day 7
Time frame: on Day 0 and Day 7
Intraocular pressure change from baseline to Day 7
Time frame: on Day 0 and Day 7
Vision acuity change from baseline to Day 7
Time frame: on Day 0 and Day 7
The mean change of pupil diameter from baseline to Day 7
Time frame: on Day 0 and Day 7
The mean change of accommodation amplitude from baseline to Day 7
Time frame: on Day 0 and Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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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.
Christopher LEUNG principal investigator
HKU Eye Centre
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 Atropine sulfate eye drops in people with Pharmacokinetics, run by Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher LEUNG (+852 25181430, cleung21@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: From 1 hour before administration to 24 hours after administration). The study lists 10 primary outcomes in all. 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 11 May 2023.