A Study of Atropine Sulfate in Healthy Chinese Volunteers

NCT ID: NCT05855018

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2023-06-30

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)

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Atropine sulfate Concentration A

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

Group Type: EXPERIMENTAL

Atropine sulfate eye drops

Intervention Type: DRUG

One drop once daily

Atropine sulfate Concentration B

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

Group Type: EXPERIMENTAL

Atropine sulfate eye drops

Intervention Type: DRUG

One drop once daily

Atropine sulfate Concentration C

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

Group Type: EXPERIMENTAL

Atropine sulfate eye drops

Intervention Type: DRUG

One drop once daily

Interventions

Atropine sulfate eye drops

One drop once daily

Intervention Type: DRUG

Other Intervention Names

Atropine sulfate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher LEUNG

Role: PRINCIPAL_INVESTIGATOR

HKU Eye Centre

Locations

HKU Eye Centre

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Christopher LEUNG

Role: CONTACT

cleung21@hku.hk

+852 25181430

Facility Contacts

Christopher LEUNG

Role: primary

cleung21@hku.hk

+852 25181430

Other Identifiers

ZKO(HK)-ATP-202111

Identifier Type: -

Identifier Source: org_study_id