Dry Eye SyndromesPhase 1NCT05219461
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
A Phase 1 study of Dry Eye Syndromes, run by Daewoong Bio Inc. at 1 site in South Korea.
Trial summary
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 51 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2019to 13 Nov 2019
- 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 51 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged from 20 to 51 at screening test
- Weight 50kg ~100kg BMI 18-27
- Those who are fully understood, voluntarily decided to participate and signed prior to screening
- Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc
Who cannot join
- Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
Read the detailed description
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
- Conditions
- Dry Eye Syndromes
- Being tested
- Single dose of rhEGF 10mcg/ml or placebo, Single dose of rhEGF 50mcg/ml or placebo, Single dose of rhEGF 100mcg/ml or placebo, Multiple dose of rhEGF 10mcg/ml or placebo, Multiple dose of rhEGF 50mcg/ml or placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of rhEGF 10mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
Single dose of rhEGF 50mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
Single dose of rhEGF 100mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Multiple dose of rhEGF 10mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
Multiple dose of rhEGF 50mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
Multiple dose of rhEGF 100mcg/ml or placeboDrug
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A rhEGF 10mcg/mL | Experimental | single dose of rhEGF 10mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily) Receives: Drug: Single dose of rhEGF 10mcg/ml or placebo |
| Group B rhEGF 50mcg/mL | Experimental | single dose of rhEGF 50mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily) Receives: Drug: Single dose of rhEGF 50mcg/ml or placebo |
| Group C rhEGF 100mcg/mL | Experimental | single dose of rhEGF 100mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily) Receives: Drug: Single dose of rhEGF 100mcg/ml or placebo |
| Group D rhEGF 10mcg/mL | Experimental | multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo Receives: Drug: Multiple dose of rhEGF 10mcg/ml or placebo |
| Group E rhEGF 50mcg/mL | Experimental | multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo Receives: Drug: Multiple dose of rhEGF 50mcg/ml or placebo |
| Group F rhEGF 100mcg/mL | Experimental | multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo Receives: Drug: Multiple dose of rhEGF 100mcg/ml or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
- sign and symptoms of AE
- physical exam, vital signs, ECG exam, lab test
- ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc
- Immunogenicity test (anti-drug antibody)
Measured: 14 days from baseline
Secondary outcomes (5)
PK characteristics
Cmax in single dose administration period
Measured: 14 days from baseline
PK characteristics
AUC in single dose administration period
Measured: 14 days from baseline
PK characteristics
Cmax in multiple dose adminitration period
Measured: 14 days from baseline
PK characteristics
AUC in multiple dose administration period
Measured: 14 days from baseline
PK characteristics
Cav in multiple dose administration period
Measured: 14 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start29 Mar 2019
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219461
- Sponsor's protocol ID
- DW_EGF102OP
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 2 Feb 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 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05219461
- Acronym / sponsor ID
- DW_EGF102OP
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daewoong Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 2 Feb 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.
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
Detailed description
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A rhEGF 10mcg/mL | Experimental | Drug: Single dose of rhEGF 10mcg/ml or placebosingle dose of rhEGF 10mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
| Group B rhEGF 50mcg/mL | Experimental | Drug: Single dose of rhEGF 50mcg/ml or placebosingle dose of rhEGF 50mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
| Group C rhEGF 100mcg/mL | Experimental | Drug: Single dose of rhEGF 100mcg/ml or placebosingle dose of rhEGF 100mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
| Group D rhEGF 10mcg/mL | Experimental | Drug: Multiple dose of rhEGF 10mcg/ml or placebomultiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo |
| Group E rhEGF 50mcg/mL | Experimental | Drug: Multiple dose of rhEGF 50mcg/ml or placebomultiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo |
| Group F rhEGF 100mcg/mL | Experimental | Drug: Multiple dose of rhEGF 100mcg/ml or placebomultiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo |
Who may qualify
- Ages
- 20 to 51 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male aged from 20 to 51 at screening test
- Weight 50kg ~100kg BMI 18-27
- Those who are fully understood, voluntarily decided to participate and signed prior to screening
- Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc
Key exclusion criteria (1 listed)
- Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
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 |
|---|---|---|
| Single dose of rhEGF 10mcg/ml or placebo6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group A rhEGF 10mcg/mL |
| Single dose of rhEGF 50mcg/ml or placebo6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group B rhEGF 50mcg/mL |
| Single dose of rhEGF 100mcg/ml or placebo6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group C rhEGF 100mcg/mL |
| Multiple dose of rhEGF 10mcg/ml or placebo6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group D rhEGF 10mcg/mL |
| Multiple dose of rhEGF 50mcg/ml or placebo6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group E rhEGF 50mcg/mL |
| Multiple dose of rhEGF 100mcg/ml or placebo6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo | Drug | Group F rhEGF 100mcg/mL |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 14 days from baseline
* sign and symptoms of AE * physical exam, vital signs, ECG exam, lab test * ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc * Immunogenicity test (anti-drug antibody)
5 secondary outcomes
PK characteristics
Time frame: 14 days from baseline
PK characteristics
Time frame: 14 days from baseline
PK characteristics
Time frame: 14 days from baseline
PK characteristics
Time frame: 14 days from baseline
PK characteristics
Time frame: 14 days from baseline
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 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Dry Eye Syndromes, run by Daewoong Bio 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 4 inclusion and 1 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 2 Feb 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. 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?
Incidence of treatment emergent adverse events (time frame: 14 days from baseline). 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 Feb 2022.