NCT05372991

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Cloudbreak Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 36 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
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.

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-01-18
• Completion: 2023-01-20
• First posted: 2022-05-13
• Last updated: 2023-01-27

Locations

1 site across 1 country: Australia