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

Phase 1

• Conditions: Healthy
• Interventions: Drug: CTO0101; Other: Placebo (vehicle)

• Registration Number: NCT05262179
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-05
• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-05-27
• Study Completion: 2022-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTO0101	CTO0101	-
Placebo (Vehicle)	Placebo (vehicle)	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss	Day8 of stage 2
t1/2,ss	Day8 of stage 2
AUCτ,ss	Day8 of stage 2
RAAUCτ	Day8 of stage 2
Tmax,ss	Day8 of stage 2

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of