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

NCT ID: NCT05372991

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-01-20

Brief Summary

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

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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.025% atropine sulphate

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.

Group Type: ACTIVE_COMPARATOR

Atropine Sulfate

Intervention Type: DRUG

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

vehicle

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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

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, Low Dose

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

Group Type: EXPERIMENTAL

CBT-009

Intervention Type: DRUG

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, Mid Dose

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

Group Type: EXPERIMENTAL

CBT-009

Intervention Type: DRUG

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, High Dose

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

Group Type: EXPERIMENTAL

CBT-009

Intervention Type: DRUG

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

Interventions

CBT-009

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

Intervention Type: DRUG

Vehicle

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

Intervention Type: DRUG

Atropine Sulfate

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

Intervention Type: DRUG

Other Intervention Names

Atropine; Without Atropine; 0.025% eyedrop aqueous solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novotech (Australia) Pty Limited

INDUSTRY

Sponsor Role: collaborator

Cloudbreak Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya Revell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sunshine Coast，Australia

Locations

USC

Brisbane, , Australia

Countries

Australia

Other Identifiers

CBT-CS201

Identifier Type: -

Identifier Source: org_study_id