A Study of Atropine Sulfate in Healthy Chinese Volunteers

Zhaoke Ophthalmology

Status and phase: Enrolling; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Atropine sulfate eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT05855018

ZKO(HK)-ATP-202111

Details and patient eligibility

About

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

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Atropine sulfate Concentration A

Experimental group

Description:

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration A), administered once daily (QD).

Treatment:

Drug: Atropine sulfate eye drops

Atropine sulfate Concentration B

Experimental group

Description:

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration B), administered once daily (QD).

Treatment:

Drug: Atropine sulfate eye drops

Atropine sulfate Concentration C

Experimental group

Description:

Subjects will be treated with atropine sulfate eye drop (at dosage Concentration C), administered once daily (QD).

Treatment:

Drug: Atropine sulfate eye drops