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Healthy SubjectPhase 1NCT03650608

A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of HL217 Eye Drop in Healthy Male Subjects

A Phase 1 study testing Cohort 1: HL217 Ophathalmic Solution QD, Cohort 2: HL217 Ophathalmic Solution BID and Cohort 3: HL217 Ophthalmic Solution QID in people with Healthy Subject, run by Hanlim Pharm. Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects. 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 Subject
What is being tested?
Cohort 1: HL217 Ophathalmic Solution QD, Cohort 2: HL217 Ophathalmic Solution BID and Cohort 3: HL217 Ophthalmic Solution QID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
Aug 2016to Aug 2017
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

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 next of kin, easily accessible, 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 > >21 units per week)
  • 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 previous participation in the current study
  • Subject under administrative or legal supervision
  • Subjects with an allergy to Fluorescein
  • History of any ocular surgery within the past 6 months prior to study participation
  • Subject who have intraocular pressure > 21 mmHg
  • Subject with acute or chronic eye problems that require eye drop at the time of screening
  • Best-corrected ETDRS visual acuity score ≤ 85 (Snellen equivalent 20/20)
  • Subject who need to wear contact lens during the study.

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 Single Dosing of HL217 Eye Drop in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerability and PK parameters of HL217 after single eye drop administration at different doses in healthy subjects.

Conditions
Healthy Subject
Being tested
Cohort 1: HL217 Ophathalmic Solution QD, Cohort 2: HL217 Ophathalmic Solution BID, Cohort 3: HL217 Ophthalmic Solution QID, Placebo Ophthalmic solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1: HL217 Ophathalmic Solution QDDrug

    Also called 3mg/mL

    Cohort 1 (Once a day)

  • Cohort 2: HL217 Ophathalmic Solution BIDDrug

    Also called 3mg/mL

    Cohort 2 (Twice a day)

  • Cohort 3: HL217 Ophthalmic Solution QIDDrug

    Also called 3mg/mL

    Cohort 3 (Four times a day)

  • Placebo Ophthalmic solutionDrug

    Also called Placebo

    Placebo

Study groups in NCT03650608
Study groupRoleWhat they receive
Cohort 1: HL217 Ophathalmic Solution QDExperimentalHL217 3mg/mL, Ophthalmic solution, two drop once a day
Receives: Drug: Cohort 1: HL217 Ophathalmic Solution QD
Cohort 2: HL217 Ophathalmic Solution BIDExperimentalHL217 3mg/mL, Ophthalmic solution, two drop twice a day
Receives: Drug: Cohort 2: HL217 Ophathalmic Solution BID
Cohort 3: HL217 Ophthalmic Solution QIDExperimentalHL217 3mg/mL, Ophthalmic solution, two drop four times a day
Receives: Drug: Cohort 3: HL217 Ophthalmic Solution QID
Placebo Ophthalmic solutionPlacebo comparatorPlacebo Ophthalmic solution, two drop once or twice or four times a day
Receives: Drug: Placebo Ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: During 72hours

  2. Local tolerance: Redness, Tingling and Other ophthalmic adverse events

    Redness, tingling and others should be checked

    Measured: During 72hours

Secondary outcomes (9)

  1. Pharmacokinetic assessment: Cmax

    observed maximum plasma concentration of HL217

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  2. Pharmacokinetic assessment: Tmax

    first time to reach Cmax

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  3. Pharmacokinetic assessment: AUClast

    area under the plasma concentration curve from administration up to the last quantifiable concentration at time 72h

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  4. Pharmacokinetic assessment: AUCinf

    area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  5. Pharmacokinetic assessment: Kel

    elimination rate constant

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  6. Pharmacokinetic assessment: T1/2

    plasma elimination half-life

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  7. Pharmacokinetic assessment: %AUCextra

    percentage of extrapolated AUCinf

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  8. Pharmacokinetic assessment: Cl/F

    clearance

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

  9. Pharmacokinetic assessment: Vd/F

    volume of distribution

    Measured: 0hour (Pre-dose), 0.25hour, 0.5hour, 0.75hour, 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 11hour, 12hour, 24hour, 72hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study startAug 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03650608
Sponsor's protocol ID
HL217-101
Status last verified
Aug 2018
First submitted
19 Jun 2018
Last updated
1 Apr 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort 1: HL217 Ophathalmic Solution QD, Cohort 2: HL217 Ophathalmic Solution BID and Cohort 3: HL217 Ophthalmic Solution QID in people with Healthy Subject, run by Hanlim Pharm. Co., Ltd..

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 18 inclusion and 24 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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: During 72hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650608.

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 1 Apr 2019.

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