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

NCT ID: NCT05262179

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-07-05

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CTO0101

Group Type EXPERIMENTAL

CTO0101

Intervention Type DRUG

1 drop/ once or three times a day/ for 17 days divided into stage2

Placebo (Vehicle)

Group Type PLACEBO_COMPARATOR

Placebo (vehicle)

Intervention Type OTHER

1 drop/ once or three times a day/ for 17 days divided into stage2

Interventions

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CTO0101

1 drop/ once or three times a day/ for 17 days divided into stage2

Intervention Type DRUG

Placebo (vehicle)

1 drop/ once or three times a day/ for 17 days divided into stage2

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taejoon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taejoon Pharmaceutical Co., Ltd.

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kwon Sukyoung, PhD

Role: CONTACT

+82-799-0175

Other Identifiers

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CTO0101

Identifier Type: -

Identifier Source: org_study_id

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