Safety and Tolerability of NTX-101 in Korean Healthy Volunteers

NCT05041543 | Completed Phase 1

• 1 other identifier: NTX-101-P1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Keywords

Ophthalmic Solutions; Eye Drops; Eye Diseases; Ischemic Optic Neuropathy; Glaucoma

Outcome Measures

Primary Outcomes (1)

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

  7 Days

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum plasma concentration (Cmax)

  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)

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

Study Arms (5)

NTX-101 Group A

EXPERIMENTAL

Day 1: One time administration, single drop. 4 subjects randomized 3:1 to NTX-101 or placebo.

Drug: NTX-101; Drug: Placebo

NTX-101 Group B

EXPERIMENTAL

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; Drug: Placebo

NTX-101 Group C

EXPERIMENTAL

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; Drug: Placebo

NTX-101 Group D

EXPERIMENTAL

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; Drug: Placebo

NTX-101 Group E

EXPERIMENTAL

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; Drug: Placebo

Interventions

NTX-101 DRUG

Eye drops, topical administration

NTX-101 Group A; NTX-101 Group B; NTX-101 Group C; NTX-101 Group D; NTX-101 Group E

Placebo DRUG

Placebo as eye drops

NTX-101 Group A; NTX-101 Group B; NTX-101 Group C; NTX-101 Group D; NTX-101 Group E

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Pinotbio, Inc.: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, 47323, South Korea

Location

MeSH Terms

Conditions

Eye Diseases; Optic Neuropathy, Ischemic; Glaucoma

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ocular Hypertension

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: March 2, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

KR (1)