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

NCT03650608 | Completed Phase 1

• 1 other identifier: HL217-101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (2)

• 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

  During 72hours

• Local tolerance: Redness, Tingling and Other ophthalmic adverse events

  Redness, tingling and others should be checked

  During 72hours

Secondary Outcomes (9)

• Pharmacokinetic assessment: Cmax

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

• Pharmacokinetic assessment: Tmax

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

• Pharmacokinetic assessment: AUClast

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

• Pharmacokinetic assessment: AUCinf

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

• Pharmacokinetic assessment: Kel

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

Study Arms (4)

Cohort 1: HL217 Ophathalmic Solution QD

EXPERIMENTAL

HL217 3mg/mL, Ophthalmic solution, two drop once a day

Drug: Cohort 1: HL217 Ophathalmic Solution QD

Cohort 2: HL217 Ophathalmic Solution BID

EXPERIMENTAL

HL217 3mg/mL, Ophthalmic solution, two drop twice a day

Drug: Cohort 2: HL217 Ophathalmic Solution BID

Cohort 3: HL217 Ophthalmic Solution QID

EXPERIMENTAL

HL217 3mg/mL, Ophthalmic solution, two drop four times a day

Drug: Cohort 3: HL217 Ophthalmic Solution QID

Placebo Ophthalmic solution

PLACEBO COMPARATOR

Placebo Ophthalmic solution, two drop once or twice or four times a day

Drug: Placebo Ophthalmic solution

Interventions

Cohort 1: HL217 Ophathalmic Solution QD DRUG

Cohort 1 (Once a day)

Also known as: 3mg/mL

Cohort 1: HL217 Ophathalmic Solution QD

Cohort 2: HL217 Ophathalmic Solution BID DRUG

Cohort 2 (Twice a day)

Also known as: 3mg/mL

Cohort 2: HL217 Ophathalmic Solution BID

Cohort 3: HL217 Ophthalmic Solution QID DRUG

Cohort 3 (Four times a day)

Also known as: 3mg/mL

Cohort 3: HL217 Ophthalmic Solution QID

Placebo Ophthalmic solution DRUG

Placebo

Also known as: Placebo

Placebo Ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg
• mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg
• bpm ≤ HR ≤ 100 bpm
• Or considered NCS by investigators
• Normal ECG recording on a 12-lead ECG:
• \< PR \< 200 ms
• QRS \< 120 ms
• QTcf ≤ 430 ms
• No sign of any trouble of sinusal automatism
• Or considered NCS by investigators

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Officials

• David Bell

  BioKinetic Europe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: August 29, 2018
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 1, 2019

Record last verified: 2018-08