HealthyPhase 1NCT05538949
Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
A Phase 1 study testing EB-203 in people with Healthy, run by EyebioKorea, Inc. at 1 site in South Korea.
Trial summary
The purpose of study is to evaluate safety, tolerability and pharmacokinetics of EB-203 Drops in adult healthy volunteers. condition/disease : AMD(Age-related Macular Degeneration) Intervention/treatment : EB-203 or Placebo Phase : Phase I Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EB-203
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2022to 7 Oct 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males between the ages of 20 and 55 years
- Body Weight > 55 kg and BMI 18 ~ 27 kg/m2
- Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
Who cannot join
- A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease
- A person who has the following diseases from medical and ophthalmic examination
- Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus
- Corrected visual acuity < 20/25 or Intraocular Pressure > 21 mmHg
- Patients who have received any eye surgery
- Other abnormal findings in ophthalmic examinations
- Other patients considered by investigators to be inappropriate as subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
The purpose of study is to evaluate safety, tolerability and pharmacokinetics of EB-203 Drops in adult healthy volunteers.
condition/disease : AMD(Age-related Macular Degeneration) Intervention/treatment : EB-203 or Placebo Phase : Phase I
Read the detailed description
Study Title : A Phase I clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Purpose : The purpose of study is to evaluate safety, tolerability and pharmacokinetics of EB-203 Drops in adult healthy volunteers
Number of Site : One site (INJE UNIVERSITY BUSAN PAIK HOSPITAL)
A total of 8 subjects will be dosed in each group(Group B, C, D) with subjects randomized 3:1 to EB-203 or placebo.(A total of 4 subjucts will be dosed in Group A) Up to 28 subjects will be enrolled in four consecutive cohorts. A safety data review as masking will be performed for 4days prior repeated treatment. Treatment of high dose will proceed following a review of safety data from low dose.
Safety and tolerability assessments and drug plasma concentrations will be evaluated throughout the study in all cohorts.
Outcome Measures :
- Primary Outcome Measures : Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
- Secondary Outcome Measures : Pharmacokinetic variables evaluation for single and repeated dose administration.
Safety Assessment :
- V/S, Physical Exam, Laboratory Exam, ECG
- Ophthalmic Exam
Investigational product(IP) :
- Active Comparator : 1 %, 2 %, 4 %, 8% of EB-203
- Placebo Comparator : Placebo
Intervention\&Number of Subject : Total 28 subjects (A Group 4, B~D Group 8)
Inclusion Criteria :
- Healthy adult males between the ages of 20 and 55 years
- Body Weight > 55 kg and BMI 18 ~ 27 kg/m2
- Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
Exclusion Criteria :
- A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease
- A person who has the following diseases from medical and ophthalmic examination
- Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus
- Corrected visual acuity < 20/25 or Intraocular Pressure > 21 mmHg
- Patients who have received any eye surgery
- Other abnormal findings in ophthalmic examinations
- Other patients considered by investigators to be inappropriate as subjects.
- Conditions
- Healthy
- Being tested
- EB-203, Placebo
- Keywords
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-203Drug
- Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1.
- Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5~Day8.
PlaceboDrug
Placebo 1Drop, QD / Day1, BID / Day5~Day8.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Participants received 1%, 2%, 4%, 8% of EB-203 eye drops. Group A : EB-203 1% eye drops, Group B : EB-203 2% eye drops, Group C : EB-203 4% eye drops, Group D : EB-203 8% eye drops Receives: Drug: EB-203 |
| Placebo group | Placebo comparator | Participants received Placebo eye drops. Group A : Placebo eye drops, Group B : Placebo eye drops, Group C : Placebo eye drops, Group D : Placebo eye drops Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
V/S, Physical Exam, ECG, Laboratory Exam, Ophthalmic Exam
Measured: Single dose : up to 4 Days, Multiple dose : up to Day10, PSV
Secondary outcomes (4)
Maximum Observed Serum Concentration (Cmax)
Cmax of EB-203 was derived across all post-dose PK collections and expressed in μg/mL.
Measured: Day1, Day2, Day8, Day9, Day10
Area under the plasma concentration versus time curve (AUC)
AUC of EB-203 in serum over the time interval from 0 extrapolated to infinity. Values for AUC of EB-203 were expressed in days by micrograms per milliliter (days•μg/mL).
Measured: Day1, Day2, Day8, Day9, Day10
Time to Maximum Serum Concentration (Tmax)
Tmax of EB-203 was based on the Cmax derived across all post-dose PK collections and expressed in hours.
Measured: Day1, Day2, Day8, Day9, Day10
Terminal Elimination Half-Life (T1/2)
T1/2 of EB-2-3 was derived across all PK collections and expressed in hours.
Measured: Day8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start29 Jun 2022
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyebioKorea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong-Lyul Ghim, Principal investigator, Busan Paik Hospital, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538949
- Sponsor's protocol ID
- EB-203-101
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05538949
- Acronym / sponsor ID
- EB-203-101
- Conditions
- Healthy
- Keywords
- Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EyebioKorea, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 14 Sep 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 study is to evaluate safety, tolerability and pharmacokinetics of EB-203 Drops in adult healthy volunteers.
condition/disease : AMD(Age-related Macular Degeneration) Intervention/treatment : EB-203 or Placebo Phase : Phase I
Detailed description
Study Title : A Phase I clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of EB-203 Eye Drops in Healthy Volunteers
Purpose : The purpose of study is to evaluate safety, tolerability and pharmacokinetics of EB-203 Drops in adult healthy volunteers
Number of Site : One site (INJE UNIVERSITY BUSAN PAIK HOSPITAL)
A total of 8 subjects will be dosed in each group(Group B, C, D) with subjects randomized 3:1 to EB-203 or placebo.(A total of 4 subjucts will be dosed in Group A) Up to 28 subjects will be enrolled in four consecutive cohorts. A safety data review as masking will be performed for 4days prior repeated treatment. Treatment of high dose will proceed following a review of safety data from low dose.
Safety and tolerability assessments and drug plasma concentrations will be evaluated throughout the study in all cohorts.
Outcome Measures :
- Primary Outcome Measures : Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
- Secondary Outcome Measures : Pharmacokinetic variables evaluation for single and repeated dose administration.
Safety Assessment :
- V/S, Physical Exam, Laboratory Exam, ECG
- Ophthalmic Exam
Investigational product(IP) :
- Active Comparator : 1 %, 2 %, 4 %, 8% of EB-203
- Placebo Comparator : Placebo
Intervention\&Number of Subject : Total 28 subjects (A Group 4, B~D Group 8)
Inclusion Criteria :
- Healthy adult males between the ages of 20 and 55 years
- Body Weight > 55 kg and BMI 18 ~ 27 kg/m2
- Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
Exclusion Criteria :
- A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease
- A person who has the following diseases from medical and ophthalmic examination
- Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus
- Corrected visual acuity < 20/25 or Intraocular Pressure > 21 mmHg
- Patients who have received any eye surgery
- Other abnormal findings in ophthalmic examinations
- Other patients considered by investigators to be inappropriate as subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: EB-203Participants received 1%, 2%, 4%, 8% of EB-203 eye drops. Group A : EB-203 1% eye drops, Group B : EB-203 2% eye drops, Group C : EB-203 4% eye drops, Group D : EB-203 8% eye drops |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants received Placebo eye drops. Group A : Placebo eye drops, Group B : Placebo eye drops, Group C : Placebo eye drops, Group D : Placebo eye drops |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males between the ages of 20 and 55 years
- Body Weight > 55 kg and BMI 18 ~ 27 kg/m2
- Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
Key exclusion criteria (7 listed)
- A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease
- A person who has the following diseases from medical and ophthalmic examination
- Other patients considered by investigators to be inappropriate as subjects.
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 |
|---|---|---|
| EB-203* Single dose : EB-203 1%, 2%, 4%, 8% 1Drop, QD / Day1. * Multiple dose : EB-203 1%, 2%, 4%, 8% 1Drop, BID / Day5~Day8. | Drug | Test group |
| PlaceboPlacebo 1Drop, QD / Day1, BID / Day5~Day8. | Drug | Placebo group |
Primary outcome
Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction)
Time frame: Single dose : up to 4 Days, Multiple dose : up to Day10, PSV
V/S, Physical Exam, ECG, Laboratory Exam, Ophthalmic Exam
4 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: Day1, Day2, Day8, Day9, Day10
Area under the plasma concentration versus time curve (AUC)
Time frame: Day1, Day2, Day8, Day9, Day10
Time to Maximum Serum Concentration (Tmax)
Time frame: Day1, Day2, Day8, Day9, Day10
Terminal Elimination Half-Life (T1/2)
Time frame: Day8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
Jong-Lyul Ghim principal investigator
Busan Paik Hospital, Inje University
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 EB-203 in people with Healthy, run by EyebioKorea, Inc. 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 23 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of AEs (Adverse Events) and ADR (Adverse Drug Reaction) (time frame: Single dose : up to 4 Days, Multiple dose : up to Day10, PSV). 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 23 Feb 2023.