HealthyPhase 1NCT05262179
A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
A Phase 1 study testing CTO0101 in people with Healthy, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101 Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CTO0101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2021to 5 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers
- Written informed consent to participate in the trial
Who cannot join
- Those who have a history of ophthalmic diseases and surgery within 5 years
- Smokers with an average daily smoking amount exceeding 10 cigarettes
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Taejoon Pharmaceutical Co., Ltd.
Seoul
About this study
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101
- Conditions
- Healthy
- Being tested
- CTO0101, Placebo (vehicle)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO0101Drug
1 drop/ once or three times a day/ for 17 days divided into stage2
Placebo (vehicle)Other
1 drop/ once or three times a day/ for 17 days divided into stage2
| Study group | Role | What they receive |
|---|---|---|
| CTO0101 | Experimental | Not described Receives: Drug: CTO0101 |
| Placebo (Vehicle) | Placebo comparator | Not described Receives: Other: Placebo (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
Measured: Day8 of stage 2
Tmax,ss
Measured: Day8 of stage 2
t1/2,ss
Measured: Day8 of stage 2
AUCτ,ss
Measured: Day8 of stage 2
RAAUCτ
Measured: Day8 of stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Oct 2021
- Primary completion27 May 2022 (estimated)
- Study completion5 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262179
- Sponsor's protocol ID
- CTO0101
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
- ClinicalTrials.gov ID
- NCT05262179
- Acronym / sponsor ID
- CTO0101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 27 May 2022 (estimated)
- Study completion
- 5 Jul 2022 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTO0101 | Experimental | Drug: CTO0101 |
| Placebo (Vehicle) | Placebo comparator | Other: Placebo (vehicle) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female volunteers
- Written informed consent to participate in the trial
Key exclusion criteria (2 listed)
- Those who have a history of ophthalmic diseases and surgery within 5 years
- Smokers with an average daily smoking amount exceeding 10 cigarettes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO01011 drop/ once or three times a day/ for 17 days divided into stage2 | Drug | CTO0101 |
| Placebo (vehicle)1 drop/ once or three times a day/ for 17 days divided into stage2 | Other | Placebo (Vehicle) |
Primary outcome
Cmax,ss
Time frame: Day8 of stage 2
Tmax,ss
Time frame: Day8 of stage 2
t1/2,ss
Time frame: Day8 of stage 2
AUCτ,ss
Time frame: Day8 of stage 2
RAAUCτ
Time frame: Day8 of stage 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTO0101 in people with Healthy, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwon Sukyoung, PhD (+82-799-0175, skkwon@taejoon.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss (time frame: Day8 of stage 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.