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Healthy VolunteersPhase 1NCT05041543

Safety and Tolerability of NTX-101 in Korean Healthy Volunteers

A Phase 1 study testing NTX-101 in people with Healthy Volunteers, run by Pinotbio, Inc. at 1 site in South Korea.

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

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 Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
NTX-101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSouth Korea
Study dates
2 Mar 2021to 15 Jun 2021
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 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • Subjects of ages between 19 and 45 years inclusive and with Body Mass Index (BMI) between 18.0 and 27.0

Who cannot join

  • 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
  • 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)
Show all 45Show fewer
  • 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
  • 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
  • AST or ALT >1.25 x upper limit of normal level
  • Total bilirubin >1.5 x upper limit of normal
  • eGFR level from CKD-EPI equation < 90 mL/min/1.73m²
  • 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.)
  • PR interval ≥ 210msec
  • QRS complex ≥ 120msec
  • QTcF interval ≥ 450msec
  • 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)
  • 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
  • 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
  • Contraceptives
  • Subjects who use inadequate contraceptives during the study that have not been clinically accepted
  • Use of intrauterine device that have been proved to prevent pregnancy
  • Use of condoms (male or female) with spermicide
  • Vasectomy
  • Tubal ligation or hysterectomy
  • Sperm donation during the study period
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inje University Busan Paik Hospital

    Busan, 47323

Other trials in South Korea

About this study

Official title: 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

Being tested
NTX-101, Placebo
Keywords
Ophthalmic Solutions, Eye Drops, Eye Diseases, Ischemic Optic Neuropathy, Glaucoma
Medical subject headings
Eye Diseases, Optic Neuropathy, Ischemic, Glaucoma

What participants receive

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

  • NTX-101Drug

    Eye drops, topical administration

  • PlaceboDrug

    Placebo as eye drops

Study groups in NCT05041543
Study groupRoleWhat they receive
NTX-101 Group AExperimentalDay 1: One time administration, single drop. 4 subjects randomized 3:1 to NTX-101 or placebo.
Receives: Drug: NTX-101; Drug: Placebo
NTX-101 Group BExperimentalDay 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.
Receives: Drug: NTX-101; Drug: Placebo
NTX-101 Group CExperimentalDay 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.
Receives: Drug: NTX-101; Drug: Placebo
NTX-101 Group DExperimentalDay 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.
Receives: Drug: NTX-101; Drug: Placebo
NTX-101 Group EExperimentalDay 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.
Receives: Drug: NTX-101; Drug: Placebo

What is being measured

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

  1. Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)

    Measured: 7 Days

Secondary outcomes (2)

  1. Pharmacokinetics (PK): Maximum plasma concentration (Cmax)

    Measured: Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration

  2. Pharmacokinetics (PK): Area under the curve (AUC)

    Measured: Pre-dose, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours after first and last administration

Timeline

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

  1. First posted13 Sep 2021
  2. Study start2 Mar 2021
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041543
Sponsor's protocol ID
NTX-101-P1
Status last verified
Apr 2022
First submitted
24 Aug 2021
Last updated
20 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NTX-101 in people with Healthy Volunteers, run by Pinotbio, 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 2 inclusion and 45 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 20 Apr 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?

Safety Evaluation: Incidence, type, and severity of Adverse Events (AE) (time frame: 7 Days). 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 NCT05041543.

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 20 Apr 2022.

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