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

NCT05372991 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-01-27

No results posted yet for this study

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.

Conditions

  • Myopia, Progressive

Interventions

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Cloudbreak Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Tanya Revell, MD · University of Sunshine Coast，Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-01-18
Completion
2023-01-20

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372991 on ClinicalTrials.gov