NCT05262179

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2021

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 21, 2022

Last Update Submit

February 21, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

CTO0101

EXPERIMENTAL
Drug: CTO0101

Placebo (Vehicle)

PLACEBO COMPARATOR
Other: Placebo (vehicle)

Interventions

CTO0101DRUG

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

CTO0101
Placebo (vehicle)OTHER

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

Placebo (Vehicle)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female volunteers
  • Written informed consent to participate in the trial

You may not qualify if:

  • Those who have a history of ophthalmic diseases and surgery within 5 years
  • Smokers with an average daily smoking amount exceeding 10 cigarettes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

RECRUITING

Central Study Contacts

Kwon Sukyoung, PhD

CONTACT

+82-799-0175skkwon@taejoon.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

October 5, 2021

Primary Completion

May 27, 2022

Study Completion

July 5, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

KR(1)