Healthy SubjectsPhase 1NCT03648346
A Dose-escalation Clinical Trial After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects
A Phase 1 study testing Cohort 1: HL217 Ophathalmic Solution BID and Cohort 2: HL217 Ophathalmic Solution QID in people with Healthy Subjects, run by Hanlim Pharm. Co., Ltd. at 1 site in France.
Trial summary
The study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Cohort 1: HL217 Ophathalmic Solution BID and Cohort 2: HL217 Ophathalmic Solution QID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2018to 25 Jan 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, aged between 18 and 50 years inclusive
- Non-smoker subject or smoker of not more than 10 cigarettes a day and able to stop smoking 24 hour prior to admission until discharge
- Body weight ≥ 50 kg and BMI between 18 and 30 kg/m²
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) including complete ocular examination
- Normal Blood Pressure (BP) and Heart Rate (HR) after 10 minutes in supine position:
- 90 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
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- 45 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
- 40 bpm ≤ HR ≤ 100 bpm,
- Or considered NCs by investigators;
- Normal ECG recording on a 12-lead ECG:
- 120 < PR < 200 ms,
- QRS < 120 ms,
- QTcf ≤ 430 ms,
- No sign of any trouble of sinusal automatism,
- Or considered NCs by investigators;
- Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator
- Normal dietary habits
- Signing a written informed consent prior to selection
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- Blood donation (including in the frame of a clinical trial) within 2 months before administration or apheresis within 20 days before administration
- General anaesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician (including allergy to fluorescein)
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- Inability to abstain from intensive muscular effort;
- No possibility of contact in case of emergency;
- Any drug or herbal medicine intake (except paracetamol) during the last 14 days prior to the first administration, any over the counter medicine or vitamin during the last 7 days prior to the first administration
- Subjects who have taken drug metabolizing enzyme inducing agents and inhibitors such as barbitals within a month prior to the first administration
- History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day);
- Excessive consumption of beverages with xanthine bases (> 5 cups or glasses / day) and not able to stop 24h prior to admission until discharge
- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2
- Major surgery (general or ocular) within 28 days prior to randomization or major surgery planned during the next 6 months
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Subjects within an exclusion period of a previous study or subjects who have taken any investigational product from other clinical trials within 60 days from the start of the study (from the administration of investigational product)
- Subjects with an allergy to Fluorescein
- Subjects with previous participation in the current study
- Subject under administrative or legal supervision
- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Block-randomized, Double Blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects
The study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). There will be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses:
- Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose),
- Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).
Read the detailed description
The purpose of this study is to evaluate the safety and tolerability of HL217 after multiple eye drop administrations at different doses in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Cohort 1: HL217 Ophathalmic Solution BID, Cohort 2: HL217 Ophathalmic Solution QID, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: HL217 Ophathalmic Solution BIDDrug
Also called 3mg/mL
Two drops of 3 mg/mL of the treatment in one eye twice a day
Cohort 2: HL217 Ophathalmic Solution QIDDrug
Also called 3mg/mL
Two drops of 3 mg/mL of the treatment in one eye 4 times a day
PlaceboDrug
Placebo eye drops
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: HL217 Ophathalmic Solution BID | Experimental | Low dose: two drops of 3 mg/mL of the treatment in one eye twice a day Receives: Drug: Cohort 1: HL217 Ophathalmic Solution BID |
| Cohort 2: HL217 Ophathalmic Solution QID | Experimental | High dose: two drops of 3 mg/mL of the treatment in one eye 4 times a day Receives: Drug: Cohort 2: HL217 Ophathalmic Solution QID |
| Placebo Ophathalmic Solution | Placebo comparator | Placebo: two drops of placebo in one eye twice a day or 4 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameter: Adverse Events (AE)
AEs will be coded according to the MedDRA. They will be classified into pre-defined standard categories according to chronological criteria
Measured: Day 1 (Pre-dose) to Day 22 (End of study visit)
Clinical parameter: Physical examination
Physical examination recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Measured: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Clinical parameter: Vital signs
Vital signs recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Measured: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Clinical parameter: ECG (ElectroCardioGram)
ECG recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Measured: Day -1, Day 1 (Before administration), Day 2, Day 15, Day 22 (End of study visit)
Clinical parameter: Laboratory parameters
All laboratory values recorded during the study will be individually listed and flagged for values outside reference ranges and for clinical relevance (assessed by investigator)
Measured: Day -1, Day 2, Day 15, Day 22 (End of study visit)
Local tolerance test
Redness, tingling and others should be checked
Measured: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Secondary outcomes (9)
Pharmacokinetic assessments: Cmax
observed maximum plasma concentration of HL217
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Tmax
first time to reach Cmax
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: AUCt
area under the plasma concentration curve from administration up to the last quantifiable concentration at time t
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: AUCinf
area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Kel
elimination rate constant
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: t1/2
plasma elimination half-life
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: %AUCextra
percentage of extrapolated AUCinf
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Vd/F
volume of distribution
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: CL/F
Clearance
Measured: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start4 Apr 2018
- Primary completion25 Jul 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, M.D, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648346
- Sponsor's protocol ID
- HL217-102
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2018
- Last updated
- 29 Mar 2019
- 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 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double Blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03648346
- Acronym / sponsor ID
- HL217-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 27 Aug 2018 (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 study is a single center, double-blind, randomized, parallel group, multiple ascending dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses during 14 days of the treatment (HL217 or placebo according to the randomization). There will be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses:
- Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose),
- Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).
Detailed description
The purpose of this study is to evaluate the safety and tolerability of HL217 after multiple eye drop administrations at different doses in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HL217 Ophathalmic Solution BID | Experimental | Drug: Cohort 1: HL217 Ophathalmic Solution BIDLow dose: two drops of 3 mg/mL of the treatment in one eye twice a day |
| Cohort 2: HL217 Ophathalmic Solution QID | Experimental | Drug: Cohort 2: HL217 Ophathalmic Solution QIDHigh dose: two drops of 3 mg/mL of the treatment in one eye 4 times a day |
| Placebo Ophathalmic Solution | Placebo comparator | Drug: PlaceboPlacebo: two drops of placebo in one eye twice a day or 4 times a day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Healthy male subject, aged between 18 and 50 years inclusive
- Non-smoker subject or smoker of not more than 10 cigarettes a day and able to stop smoking 24 hour prior to admission until discharge
- Body weight ≥ 50 kg and BMI between 18 and 30 kg/m²
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) including complete ocular examination
- Normal Blood Pressure (BP) and Heart Rate (HR) after 10 minutes in supine position:
Key exclusion criteria (20 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- Blood donation (including in the frame of a clinical trial) within 2 months before administration or apheresis within 20 days before administration
- General anaesthesia within 3 months before administration
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 |
|---|---|---|
| Cohort 1: HL217 Ophathalmic Solution BIDAlso: 3mg/mLTwo drops of 3 mg/mL of the treatment in one eye twice a day | Drug | Cohort 1: HL217 Ophathalmic Solution BID |
| Cohort 2: HL217 Ophathalmic Solution QIDAlso: 3mg/mLTwo drops of 3 mg/mL of the treatment in one eye 4 times a day | Drug | Cohort 2: HL217 Ophathalmic Solution QID |
| PlaceboPlacebo eye drops | Drug | Placebo Ophathalmic Solution |
Primary outcome
Clinical parameter: Adverse Events (AE)
Time frame: Day 1 (Pre-dose) to Day 22 (End of study visit)
AEs will be coded according to the MedDRA. They will be classified into pre-defined standard categories according to chronological criteria
Clinical parameter: Physical examination
Time frame: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Physical examination recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Clinical parameter: Vital signs
Time frame: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Vital signs recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Clinical parameter: ECG (ElectroCardioGram)
Time frame: Day -1, Day 1 (Before administration), Day 2, Day 15, Day 22 (End of study visit)
ECG recorded during the study will be individually listed and quantitative parameters will be summarized by using descriptive statistics
Clinical parameter: Laboratory parameters
Time frame: Day -1, Day 2, Day 15, Day 22 (End of study visit)
All laboratory values recorded during the study will be individually listed and flagged for values outside reference ranges and for clinical relevance (assessed by investigator)
Local tolerance test
Time frame: Day -1, Day 1 (Before administration, 4h, 8h, 12h), Day 2 (24h), Day 3 to 15, Day 22 (End of study visit)
Redness, tingling and others should be checked
9 secondary outcomes
Pharmacokinetic assessments: Cmax
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Tmax
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: AUCt
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: AUCinf
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Kel
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: t1/2
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: %AUCextra
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: Vd/F
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
Pharmacokinetic assessments: CL/F
Time frame: 0h, 12h, 12h05min, 12h15min, 12h30min, 12h45min, 13h, 14h, 15h, 16h, 18h, 20h, 24h, 28h and 32hours after the last administration at Day 14
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 29 Mar 2019.
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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.
Yves Donazzolo, M.D principal investigator
Eurofins Optimed
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 Cohort 1: HL217 Ophathalmic Solution BID and Cohort 2: HL217 Ophathalmic Solution QID in people with Healthy Subjects, run by Hanlim Pharm. Co., Ltd. at 1 site in France.
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 19 inclusion and 20 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 29 Mar 2019. 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 France. 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?
Clinical parameter: Adverse Events (AE) (time frame: Day 1 (Pre-dose) to Day 22 (End of study visit)). The study lists 6 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 29 Mar 2019.