A Phase 1 Clinical Trial to Explore Systemic Exposure of... | NCT05262179

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

NCT05262179

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 2, 2022Actual

Enrollment

16Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

CTO0101
Placebo (vehicle)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2021Actual

Primary Completion Date

May 27, 2022Estimated

Completion Date

Jul 5, 2022Estimated

First Submitted Date

Feb 21, 2022

First Submission Date that Met QC Criteria

Feb 21, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTO0101	Experimental		Drug: CTO0101
Placebo (Vehicle)	Placebo Comparator		Other: Placebo (vehicle)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTO0101	Drug	1 drop/ once or three times a day/ for 17 days divided into stage2	CTO0101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax,ss		Day8 of stage 2
Tmax,ss		Day8 of stage 2
t1/2,ss		Day8 of stage 2
AUCτ,ss		Day8 of stage 2
RAAUCτ		Day8 of stage 2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kwon Sukyoung, PhD	Contact	+82-799-0175		skkwon@taejoon.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taejoon Pharmaceutical Co., Ltd.	Recruiting	Seoul			South Korea