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

Cloudbreak Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myopia, Progressive

Treatments: Drug: Vehicle; Drug: CBT-009; Drug: Atropine Sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372991

CBT-CS201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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84 participants in 5 patient groups, including a placebo group

0.025% atropine sulphate

Active Comparator group

Description:

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.

Treatment:

Drug: Atropine Sulfate

vehicle

Placebo Comparator group

Description:

CBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance.

Treatment:

Drug: Vehicle

CBT-009, Low Dose

Experimental group

Description:

CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance.

Treatment:

Drug: CBT-009

CBT-009, Mid Dose

Experimental group

Description:

CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance.

Treatment:

Drug: CBT-009

CBT-009, High Dose

Experimental group

Description:

CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance.

Treatment:

Drug: CBT-009