A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
Sponsor
Taejoon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05262179
Collaborator
(none)
16
1
2
9
1.8
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
Actual Study Start Date
:
Oct 5, 2021
Anticipated Primary Completion Date
:
May 27, 2022
Anticipated Study Completion Date
:
Jul 5, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CTO0101
|
Drug: CTO0101
1 drop/ once or three times a day/ for 17 days divided into stage2
|
| Placebo Comparator: Placebo (Vehicle)
|
Other: Placebo (vehicle)
1 drop/ once or three times a day/ for 17 days divided into stage2
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taejoon Pharmaceutical Co., Ltd. | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Taejoon Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Taejoon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05262179
Other Study ID Numbers:
- CTO0101
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No