Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop

Study Overview
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Brief Summary
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This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. CBT-009 has the active ingredient of atropine, which at low doses, has shown to be effective in slowing down myopic deterioration. Current atropine products are prone to degradation once the container is open to the air. ADS Pharmaceutical has developed a novel atropine formulation.

Detailed Description
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Type of Study: Stage 1: Single center, open-labeled, vehicle-controlled, single ascending dose. Stage 2: Parallel, double-masked, randomized, vehicle-controlled with dosing once-daily in one eye. Study Population: Male or female healthy volunteers aged 18-36 years. Number of Subjects and Sites: Stage 1: Enrollment is planned for approximately 32 healthy volunteers with 8 subjects per cohort for a total of 4 cohorts. Stage 2: Enrollment is planned for approximately 50 healthy volunteers with 25 subjects per cohort for a total of 2 cohorts. Duration of Study Participation: Stage 1: One day. Stage 2: 28 days of treatment with no follow-up observations.

Official Title
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A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Drug: CBT-009
* Drug: Vehicle
* Drug: Atropine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer without any active ocular diseases 18-36 years of age Able to provide written informed consent and comply with study assessments for the full duration of the study Exclusion Criteria: Uncontrolled systemic disease Active ocular disease Any ocular surgical procedure within the last 3 months Current enrollment in an investigational drug or device study or participation in such as study within 30 days prior to entry into this study Any condition or situation which, in the investigator's opinion, may put the volunteer at significant risk, may confound the study results, or may interfere significantly with the volunteer's participation in the study. Allergic or sensitive to Atropine study medication or formulation excipient Smoking during the study Female patients who are pregnant, nursing, or planning a pregnancy during the study Current or anticipated use of topical ophthalmic medications are prohibited during the study. Volunteers must have discontinued use of ophthalmic medications for at least 2 weeks prior to Day 1 visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.025% atropine sulphate<br>The comparator formulation of 0.025% atropine sulfate monohydrate in normal saline will be prepared by diluting commercial 1% atropine sulphate solution with physiologic saline. | Drug: Atropine Sulfate<br>* This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.<br>* Other names: 0.025% eyedrop aqueous solution;|
| Placebo Comparator: vehicle<br>CBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance. | Drug: Vehicle<br>* This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.<br>* Other names: Without Atropine;|
| Experimental: CBT-009, Low Dose<br>CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance. | Drug: CBT-009<br>* This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.<br>* Other names: Atropine;|
| Experimental: CBT-009, Mid Dose<br>CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance. | Drug: CBT-009<br>* This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.<br>* Other names: Atropine;|
| Experimental: CBT-009, High Dose<br>CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance. | Drug: CBT-009<br>* This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.<br>* Other names: Atropine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety on near visual acuity | Near visual acuity will be assessed using best-corrected distance spectacle correction with a reduced logMAR reading chart placed at 40 cm under well-lit conditions at Day 28. | 28 days | 
| Safety on accommodation | The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28. | 28 days | 
| Safety on mesopic and photopic pupil | Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28. | 28 days |