Clinical trial
A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
Name
ZKO(HK)-ATP-202111
Description
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
Trial arms
Trial start
2023-05-09
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Atropine sulfate eye drops
One drop once daily
Arms:
Atropine sulfate Concentration A, Atropine sulfate Concentration B, Atropine sulfate Concentration C
Other names:
Atropine sulfate
Size
30
Primary endpoint
Maximum concentration (Cmax)
From 1 hour before administration to 24 hours after administration
Time of Cmax (Tmax)
From 1 hour before administration to 24 hours after administration
Time of half-life (t1/2)
From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to last draw time (AUC0-t)
From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞))
From 1 hour before administration to 24 hours after administration
Minimum concentration (Cmin)
From 1 hour before administration to 24 hours after administration
Volume of distribution (Vd)
From 1 hour before administration to 24 hours after administration
Elimination rate constant (Kel)
From 1 hour before administration to 24 hours after administration
Clearance (CL)
From 1 hour before administration to 24 hours after administration
Apparent Clearance (CL/F)
From 1 hour before administration to 24 hours after administration
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-05-11
1 organization
1 product
1 indication
Organization
Zhaoke Ophthalmology PharmaceuticalProduct
Atropine sulfateIndication
pharmacokinetics