A Randomized, Double-blinded, Placebo-controlled, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of NTX-101 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- NTX-101
- Conditions
- Healthy Volunteers
- Sponsor
- Pinotbio, Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
NTX-101 Group A
Day 1: One time administration, single drop. 4 subjects randomized 3:1 to NTX-101 or placebo.
Intervention: NTX-101
NTX-101 Group A
Day 1: One time administration, single drop. 4 subjects randomized 3:1 to NTX-101 or placebo.
Intervention: Placebo
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.
Intervention: NTX-101
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.
Intervention: Placebo
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.
Intervention: NTX-101
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.
Intervention: Placebo
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.
Intervention: NTX-101
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.
Intervention: Placebo
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.
Intervention: NTX-101
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Time Frame: 7 Days
Secondary Outcomes
- 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)
- 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)