Safety and Tolerability of NTX-101 in Korean Healthy Volunteers

April 19, 2022 updated by: Pinotbio, Inc.

A Randomized, Double-blinded, Placebo-controlled, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of NTX-101 in Healthy Volunteers

A double-blinded, placebo controlled, multiple dose, randomized, single site, phase 1 clinical trial to evaluate safety, tolerability, and pharmacokinetics of NTX-101 topical eye drop in Korean healthy volunteers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult subjects who have voluntarily agreed to the participation of this study upon sufficient explanation of the purpose, procedure, and the characteristics of the experimental drug of the trial prior to participation
  2. Subjects of ages between 19 and 45 years inclusive and with Body Mass Index (BMI) between 18.0 and 27.0

Exclusion Criteria:

  1. Clinical History

    • Subjects with a clinically significant history of the gastrointestinal, hepatic, cardiovascular, pulmonary, endocrine, renal, urological, immunologic, musculoskeletal, neurological, psychiatric, hematological, ocular, otolaryngologic disorder not deemed acceptable by the PI
    • Subjects with a clinically significant history of disorder that can affect the experimental drug's absorption, distribution, metabolism, and excretion (e.g. Crohn's disease, peptic ulcer, surgery to stomach and intestine (excluding appendectomy and herniorrhaphy)) not deemed acceptable by the PI

  2. Ocular History

    • Subjects with a suspected history or symptoms of visual organ disorder, including keratitis, uveitis, retinitis, dry eye syndrome, and strabismus.
    • Subjects with corrected visual acuity of below 20/40 (0.5 in Han Chun Suk chart)
    • Subjects with history of ocular surgery, excluding those who received laser eye surgery 6 months prior to screening
    • Subjects who have experienced complications from wearing contact lens, used contact lens in the past month, or cannot adhere to the prohibition of using contact lens during the study
    • Subjects with other anomalies discovered at the ocular examination upon screening

  3. Clinical Examination

    • Subjects with a resting blood pressure of >140 mmHg or <90 mmHg diastolic, >90 mmHg or <60 mmHg systolic, or heartrate exceeding 100 per minute

    • Subjects with inadequate levels of the following criteria upon repeated examination

      1. AST or ALT >1.25 x upper limit of normal level
      2. Total bilirubin >1.5 x upper limit of normal
      3. eGFR level from CKD-EPI equation < 90 mL/min/1.73m²
      4. Positive blood serum result (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test)

    • Subjects who show anomalies or have the following results repeatedly in the electrocardiogram (including, but not limited to, major arrhythmia, multifocal PVC, 2° A-V block anomaly, etc.)

      1. PR interval ≥ 210msec
      2. QRS complex ≥ 120msec
      3. QTcF interval ≥ 450msec

  4. Allergy, Hypersensitivity, or Substance Abuse

    • Subjects with hypersensitivity to the components or additives of the experimental drug
    • Subjects with clinically significant allergy (excluding mild allergic rhinitis that does not require medication) or prior history of hypersensitivity to other drugs (aspirin, antibiotics, etc.)
    • Subject with history of substance abuse (especially drugs that act on Central Nervous System, such as sedatives, Central Nervous System depressants, opioids, or psychotropic drugs, etc.) or positive result from screening test (methamphetamine, marijuana, opium, cocaine, amphetamine, ecstasy)

  5. Prohibited drug/food

    • Subjects who have taken drug metabolism stimulator or suppressor within 1 month of the first experimental drug administration
    • Subjects who have received vaccination within 8 weeks prior to the first experimental drug administration or is expecting to receive before the end of study
    • Subjects who have taken prescribed medicine (including prescribed herbal medicine) 14 days prior or over-the-counter drugs (including vitamin supplements) 10 days prior to the administration of the experimental drugs that may affect the study determined by the PI
    • Subjects who have taken within 7 days prior to the first administration of the experimental drug or cannot stop taking food that may affect the drug's absorption, distribution, metabolism, and excretion (e.g. grapefruit juice, garlic extract, broccoli, kale, etc.)
    • Subjects who have participated in other pharmacokinetic or other clinical studies and have taken experimental drugs 6 months prior to this study

  6. Blood Donation and Transfusion

    • Subjects who have donated whole blood within 2 months prior to the first administration of the experimental drug or have donated blood components within 1 month prior to the administration of the experimental drug
    • Subjects who have received blood transfusion within 1 month prior to the administration of the experimental drug

  7. Contraceptives

    • Subjects who use inadequate contraceptives during the study that have not been clinically accepted

      1. Use of intrauterine device that have been proved to prevent pregnancy
      2. Use of condoms (male or female) with spermicide
      3. Vasectomy
      4. Tubal ligation or hysterectomy
      5. Sperm donation during the study period

  8. Others

    • Subjects who refuses to stop taking xanthine-containing food from 3 days prior to the first administration of the experimental drug until the end of study (e.g. coffee, green tea, black tea, cola, cocoa, chocolate, energy drinks, etc.)
    • Subjects who refuses to stop drinking excessive alcohol (>30 g/day) from 3 days prior to the first administration of the experimental drug until the end of study
    • Subjects who refuses to stop smoking during the hospitalization period
    • Subjects deemed unfit for this study by the Principal Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NTX-101 Group A
Day 1: One time administration, single drop. 4 subjects randomized 3:1 to NTX-101 or placebo.
Drug: NTX-101
Eye drops, topical administration
Drug: Placebo
Placebo as eye drops
Experimental: NTX-101 Group B
Day 1: One time administration, single drop. Day 3-7: Two time administration, one drop each time (12 hours apart). Total 9 times administration. 8 subjects randomized 6:2 to NTX-101 or placebo.
Drug: NTX-101
Eye drops, topical administration
Drug: Placebo
Placebo as eye drops
Experimental: NTX-101 Group C
Day 1: One time administration, single drop. Day 3-7: Two time administration, one drop each time (12 hours apart). Total 9 times administration. 8 subjects randomized 6:2 to NTX-101 or placebo.
Drug: NTX-101
Eye drops, topical administration
Drug: Placebo
Placebo as eye drops
Experimental: NTX-101 Group D
Day 1: One time administration, two drops. Day 3-7: Two time administration, two drops each time (12 hours apart). Total 9 times administration. 8 subjects randomized 6:2 to NTX-101 or placebo.
Drug: NTX-101
Eye drops, topical administration
Drug: Placebo
Placebo as eye drops
Experimental: NTX-101 Group E
Day 1: One time administration, four drops. Day 3-7: Two time administration, four drop each time (12 hours apart). Total 9 times administration. 8 subjects randomized 6:2 to NTX-101 or placebo.
Drug: NTX-101
Eye drops, topical administration
Drug: Placebo
Placebo as eye drops

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Time Frame: 7 Days
7 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum plasma concentration (Cmax)
Time Frame: Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration
Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration
Pharmacokinetics (PK): Area under the curve (AUC)
Time Frame: Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration
Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pinotbio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTX-101-P1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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