A Study of Atropine Sulfate in Healthy Chinese Volunteers

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855018
• Other study ID #: ZKO(HK)-ATP-202111
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2023
• Est. completion date: June 2023

Study information

• Verified date: May 2023
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: Christopher LEUNG
• Phone: +852 25181430
• Email: cleung21[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Atropine sulfate eye drops
One drop once daily

Locations

Country	Name	City	State
China	HKU Eye Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Area Under time-concentration Curve from 0 to infinity time (AUC(0-8))	Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics	From 1 hour before administration to 24 hours after administration
Primary	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
Primary	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
Primary	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
Primary	Clearance (CL)	Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics	From 1 hour before administration to 24 hours after administration
Primary	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	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	on Day 0 and Day 7
Secondary	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	on Day 0 and Day 7
Secondary	Intraocular pressure change from baseline to Day 7	Use non-contact tonometer to measure intraocular pressure	on Day 0 and Day 7
Secondary	Vision acuity change from baseline to Day 7	Using Best-corrected LogMAR scale	on Day 0 and Day 7
Secondary	The mean change of pupil diameter from baseline to Day 7	Use ophthalmic biometry equipment to measure pupil diameter	on Day 0 and Day 7
Secondary	The mean change of accommodation amplitude from baseline to Day 7	Use a Phoropter to measure the accommodation amplitude using the negative lens method	on Day 0 and Day 7