Clinical trial NCT05855018: A Study of Atropine Sulfate in Healthy Chinese Volunteers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Time of Cmax (Tmax)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Time of half-life (t1/2)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Area Under time-concentration Curve from 0 to last draw time (AUC0-t)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞))
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Minimum concentration (Cmin)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Volume of distribution (Vd)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Elimination rate constant (Kel)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Clearance (CL)
timeFrame: From 1 hour before administration to 24 hours after administration
measure: Apparent Clearance (CL/F)
timeFrame: From 1 hour before administration to 24 hours after administration
Secondary outcomes:
measure: Slit-lamp eye examination results change from baseline to Day 7
timeFrame: on Day 0 and Day 7
measure: Fundoscopy eye examination results change from baseline to Day 7
timeFrame: on Day 0 and Day 7
measure: Intraocular pressure change from baseline to Day 7
timeFrame: on Day 0 and Day 7
measure: Vision acuity change from baseline to Day 7
timeFrame: on Day 0 and Day 7
measure: The mean change of pupil diameter from baseline to Day 7
timeFrame: on Day 0 and Day 7
measure: The mean change of accommodation amplitude from baseline to Day 7
timeFrame: on Day 0 and Day 7
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: HKU Eye Centre
Study officials:
affiliation: HKU Eye Centre
name: Christopher LEUNG
role: PRINCIPAL_INVESTIGATOR
References: