Clinical trial NCT05372991: Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
Official title: A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myopia, Progressive
Lead sponsor: Cloudbreak Therapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2022-05-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety on near visual acuity
timeFrame: 28 days
measure: Safety on accommodation
timeFrame: 28 days
measure: Safety on mesopic and photopic pupil
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: USC
Study officials:
affiliation: University of Sunshine Coast，Australia
name: Tanya Revell, MD
role: PRINCIPAL_INVESTIGATOR
References: