Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
ConditionXerophthalmia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorHuons Co., Ltd.
About this trial
The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult subjects aged 19 to 50 years at the time of screening (Visit 1).
Subjects with a body weight of 50.0 kg or more, and a body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of screening (Visit 1).
Subjects who have received sufficient explanation about the clinical trial, fully understand it, and have voluntarily decided to participate and signed the written informed consent.
Subjects deemed suitable as participants for this clinical trial based on the investigators judgment after physical examination, clinical laboratory tests, and medical history obtained during screening (Visit 1).
Disqualifiers
Subjects with clinically significant diseases or history of diseases related to the liver, kidneys, cardiovascular system, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, mood disorders, obsessive-compulsive disorder), hematologic/oncologic system, or urinary system (chronic or recurrent urinary tract infections).
Subjects with hepatitis B or C.
Corrected visual acuity of 20/40 or less.
Intraocular pressure exceeding 21 mmHg in either eye.
Trial design
Design model
Parallel
Treatments tested in this trial
NCP112
DrugNCP112 topical ophthalmic solution
NCP112 Placebo
DrugPlacebo comparator
Treatment groups
60 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Single Ascending dose NCP112 Dose AExperimental treatment 1 intervention
Group B: Single Ascending dose NCP112 Dose A, PlaceboPlacebo comparator 1 intervention
Group C: Single Ascending dose NCP112 Dose BExperimental treatment 1 intervention
Group D: Single Ascending dose NCP112 Dose B, PlaceboPlacebo comparator 1 intervention
Group E: Single Ascending dose NCP112 Dose CExperimental treatment 1 intervention
Group F: Single Ascending dose NCP112 Dose C, PlaceboPlacebo comparator 1 intervention
Group G: Multiple Ascending dose NCP112 Dose AExperimental treatment 1 intervention
Group H: Multiple Ascending dose NCP112 Dose A, PlaceboPlacebo comparator 1 intervention
Group I: Multiple Ascending dose NCP112 Dose BExperimental treatment 1 intervention
Group J: Multiple Ascending dose NCP112 Dose B, PlaceboPlacebo comparator 1 intervention
Group K: Multiple Ascending dose NCP112 Dose CExperimental treatment 1 intervention
Group L: Multiple Ascending dose NCP112 Dose C, PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Eye irritation(Likert scale)
Local safety assessment
Time frame
Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 222
Eye redness(Likert scale)
Local safety assessment
Time frame
Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 223
Intraocular pressure
Opthalmic examination
Time frame
Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 224
History taking
Opthalmic examination
Time frame
Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22Secondary outcomes
1
Cmax
Single dose - Evaluation of pharmacokinetic profile
Time frame
Day 1~Day 4 (Blood sampling at specified times within the time frame)2
AUClast
Single dose - Evaluation of pharmacokinetic profile
Time frame
Day 1~Day 4 (Blood sampling at specified times within the time frame)3
Tmax
Single dose - Evaluation of pharmacokinetic profile
Time frame
Day 1~Day 4 (Blood sampling at specified times within the time frame)4
AUCinf
Single dose - Evaluation of pharmacokinetic profile
Time frame
Day 1~Day 4 (Blood sampling at specified times within the time frame)Sponsors and contacts
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Source ClinicalTrials.gov