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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05262179

Enrollment

Registered

2022-03-02

Start date

2021-10-05

Completion date

2022-07-05

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGCTO0101

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

OTHERPlacebo (vehicle)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

South Korea

Contacts

Primary ContactKwon Sukyoung, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026