A Randomized, Double-blind, Parallel, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Study to Assess the Safety, and Local Tolerance, Pharmacokinetics After Application of NCP112 Eye Drop in Healthy Subjects
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 50
Healthy Volunteers: t
View:
• 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).
• ※ Body Mass Index (BMI, kg/m²) = Weight (kg) / \[Height (m)\]²
• 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).
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eunsoo Sim
minie30@huons.com
+82-70-7492-5070
Backup
Soyoung Lee, MS
soyoung.lee@huons.com
+82-70-7492-5736
Time Frame
Start Date:2024-07-11
Estimated Completion Date:2026-01-30
Participants
Target number of participants:60
Treatments
Experimental: Single Ascending dose NCP112 Dose A
NCP112 is administered once at a specified time in Day 1
Placebo_comparator: Single Ascending dose NCP112 Dose A, Placebo
NCP112 Placebo is administered once at a specified time in Day 1
Experimental: Single Ascending dose NCP112 Dose B
NCP112 is administered once at a specified time in Day 1
Placebo_comparator: Single Ascending dose NCP112 Dose B, Placebo
NCP112 Placebo is administered once at a specified time in Day 1
Experimental: Single Ascending dose NCP112 Dose C
NCP112 is administered once at a specified time in Day 1
Placebo_comparator: Single Ascending dose NCP112 Dose C, Placebo
NCP112 Placebo is administered once at a specified time in Day 1
Experimental: Multiple Ascending dose NCP112 Dose A
NCP112 is administered twice daily. \[time frame: Day 1- Day 14\]
Placebo_comparator: Multiple Ascending dose NCP112 Dose A, Placebo
NCP112 Placebo is administered twice daily. \[time frame: Day 1- Day 14\]
Experimental: Multiple Ascending dose NCP112 Dose B
NCP112 is administered twice daily.\[time frame: Day 1- Day 14\]