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NCT05262179 Clinical Trial

A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults

Healthy Clinical Trial

Official title:
A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05262179
Other study ID # CTO0101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 5, 2021
Est. completion date July 5, 2022

Study information
Verified date February 2022
Source Taejoon Pharmaceutical Co., Ltd.
Contact Kwon Sukyoung, PhD
Phone +82-799-0175
Email skkwon@taejoon.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101

Recruitment information / eligibility
Status Recruiting
Enrollment 16
Est. completion date July 5, 2022
Est. primary completion date May 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Healthy male and female volunteers - Written informed consent to participate in the trial Exclusion Criteria: - Those who have a history of ophthalmic diseases and surgery within 5 years - Smokers with an average daily smoking amount exceeding 10 cigarettes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CTO0101
1 drop/ once or three times a day/ for 17 days divided into stage2
Other:
• Placebo (vehicle)
1 drop/ once or three times a day/ for 17 days divided into stage2

Locations
Country Name City State
Korea, Republic of Taejoon Pharmaceutical Co., Ltd. Seoul

Sponsors (1)
Lead Sponsor Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss Day8 of stage 2
Primary Tmax,ss Day8 of stage 2
Primary t1/2,ss Day8 of stage 2
Primary AUCt,ss Day8 of stage 2
Primary RAAUCt Day8 of stage 2
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