A Study of Atropine Sulfate in Healthy Chinese Volunteers
A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2023
CompletedStudy Start
First participant enrolled
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 11, 2023
May 1, 2023
23 days
April 23, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (10)
Maximum concentration (Cmax)
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)
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)
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)
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-∞))
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)
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)
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)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
From 1 hour before administration to 24 hours after administration
Clearance (CL)
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)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
From 1 hour before administration to 24 hours after administration
Secondary Outcomes (6)
Slit-lamp eye examination results change from baseline to Day 7
on Day 0 and Day 7
Fundoscopy eye examination results change from baseline to Day 7
on Day 0 and Day 7
Intraocular pressure change from baseline to Day 7
on Day 0 and Day 7
Vision acuity change from baseline to Day 7
on Day 0 and Day 7
The mean change of pupil diameter from baseline to Day 7
on Day 0 and Day 7
- +1 more secondary outcomes
Study Arms (3)
Atropine sulfate Concentration A
EXPERIMENTALSubjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD).
Atropine sulfate Concentration B
EXPERIMENTALSubjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD).
Atropine sulfate Concentration C
EXPERIMENTALSubjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD).
Interventions
One drop once daily
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HKU Eye Centre
Hong Kong, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher LEUNG
HKU Eye Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2023
First Posted
May 11, 2023
Study Start
May 9, 2023
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share