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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
NCP112 topical ophthalmic solution
Placebo comparator
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, South Korea
RECRUITINGEye irritation(Likert scale)
Local safety assessment
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Eye redness(Likert scale)
Local safety assessment
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Intraocular pressure
Opthalmic examination
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
History taking
Opthalmic examination
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Corrected vision test
Opthalmic examination
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Adverse events
Including subjective and objective symptoms
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Vital signs
Blood pressure
Time frame: Single dose Day -1 ~ Day 4, Multiple dose Day -1 ~ Day 22
Cmax
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUClast
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Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Tmax
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
AUCinf
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
t1/2
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
CL/F
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Vz/F
Single dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 4 (Blood sampling at specified times within the time frame)
Cmax
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmax,ss
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
AUCtau,ss
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Cmin,ss
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
t1/2,ss
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
CLss/F
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Vz,ss/F
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
PTF
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
R
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)
Tmax,ss
Multiple dose - Evaluation of pharmacokinetic profile
Time frame: Day 1~Day 22 (Blood sampling at specified times within the time frame)