A Study of Atropine Sulfate in Healthy Chinese Volunteers

May 2, 2023 updated by: Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Christopher LEUNG
  • Phone Number: +852 25181430
  • Email: cleung21@hku.hk

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • HKU Eye Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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;
  2. 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;
  3. 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;

Exclusion Criteria:

  1. Subject with any eye with corrected visual acuity <1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination.
  2. Subject with history of eye diseases, including the history of internal eye surgery or laser surgery.
  3. 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.
  4. Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops.
  5. On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months.
  6. 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.
  7. Subject has used any local or systemic drugs (including any prescription or over-the-counter drugs) within 2 weeks before screening.
  8. Subject has participated in interventional clinical trials within 3 months before screening.
  9. Subject who has worn contact lenses or cosmetic contact lenses within 1 weeks before screening.
  10. Subject who is pregnant or breastfeeding.
  11. The investigator believes that the subject is not suitable to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Atropine sulfate Concentration A
Subjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD).
Drug: Atropine sulfate eye drops
One drop once daily
Other Names:
  • Atropine sulfate
Experimental: Atropine sulfate Concentration B
Subjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD).
Drug: Atropine sulfate eye drops
One drop once daily
Other Names:
  • Atropine sulfate
Experimental: Atropine sulfate Concentration C
Subjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD).
Drug: Atropine sulfate eye drops
One drop once daily
Other Names:
  • Atropine sulfate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration
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
From 1 hour before administration to 24 hours after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Slit-lamp eye examination results change from baseline to Day 7
Time Frame: on Day 0 and Day 7
Evaluate the anterior segment of the eye, including the eyelids, cornea, conjunctiva, anterior chamber, iris and lens, and record abnormalities
on Day 0 and Day 7
Fundoscopy eye examination results change from baseline to Day 7
Time Frame: on Day 0 and Day 7
Evaluate the condition of the fundus, including the vitreous body, optic disc, macula, peripheral retina and retinal blood vessels
on Day 0 and Day 7
Intraocular pressure change from baseline to Day 7
Time Frame: on Day 0 and Day 7
Use non-contact tonometer to measure intraocular pressure
on Day 0 and Day 7
Vision acuity change from baseline to Day 7
Time Frame: on Day 0 and Day 7
Using Best-corrected LogMAR scale
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
Use ophthalmic biometry equipment to measure pupil diameter
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
Use a Phoropter to measure the accommodation amplitude using the negative lens method
on Day 0 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher LEUNG, HKU Eye Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZKO(HK)-ATP-202111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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