NCT06969001

Brief Summary

To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

May 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

April 28, 2025

Last Update Submit

September 7, 2025

Conditions

Wet Age Related Macular Degeneration

Keywords

axitinibeyedroptyrosine kinase inhibitorwetAMDCNVPhase1SCAI-005

Outcome Measures

Primary Outcomes (1)

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

    15days

Other Outcomes (15)

  • Cmax

    Pre-dose, 10, 20, 30, 45 minutes, 1, 2, 4, 8, 12 hours after last administration

  • Tmax

    Pre-dose, 10, 20, 30, 45 minutes, 1, 2, 4, 8, 12 hours after last administration

  • t1/2

    Pre-dose, 10, 20, 30, 45 minutes, 1, 2, 4, 8, 12 hours after last administration

  • +12 more other outcomes

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Day 1: One time administration, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort

Drug: SCAI-005 0.04% or placeboDrug: SCAI-005 0.08% or placeboDrug: SCAI-005 0.08% or placebo 2drops

Multiple Ascending Dose

EXPERIMENTAL

Three times administration daily (TID) for 7days, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort

Drug: SCAI-005 0.04% or placeboDrug: SCAI-005 0.08% or placeboDrug: SCAI-005 0.08% or placebo 2drops

Interventions

SCAI-005 0.04% or placeboDRUG

axitinib 0.014mg or placebo

Multiple Ascending DoseSingle Ascending Dose
SCAI-005 0.08% or placeboDRUG

axitinib 0.028mg or placebo

Multiple Ascending DoseSingle Ascending Dose
SCAI-005 0.08% or placebo 2dropsDRUG

axitinib 0.056mg or placebo

Multiple Ascending DoseSingle Ascending Dose

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult subjects aged 19 to 50 years at the time of screening
  • Male subjects with a body weight of 55.0 kg or more, Female subjects with a body weight of 50kg or more, and within ±20% of ideal body weight at the time of screening
  • Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study

You may not qualify if:

  • Subjects with symptoms suggestive of an acute disease at the time of screening
  • Subjects with clinically significant and active diseases related to cardiovascular system, gastrointestinal system, respiratory system, endocrine system, neuropsychiatric system, hematologic/oncologic system
  • Subjects meeting any of the following criteria based on examination during screening:
  • AST, ALT \> 1.5 X ULN
  • Total bilitubin \> 1.5 X ULN
  • eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m2
  • serological test result = positive
  • Subjects with systolic blood pressure of 90 mmHg or less, or 150 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 100 mmHg or more after sitting for at least 5 minutes during screening (Visit 1)
  • Subjects meeting any of the following criteria based on ophthalmological examination during screening:
  • Best corrected visual acuity \< 0.6
  • IOP \> 21 mmHg
  • difference in IOP between both eyes \> 4mmHg
  • subjects who are assessed ineligible due to abnormal findings in other ophthalmonlogical examinations
  • History or suspicion of conditions affecting visual organs such as keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus within 12months prior to screening visit
  • Ophthalmologic surgery within 12 months prior to screening visit
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University, Seoul ST. Mary's Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 13, 2025

Study Start

May 29, 2025

Primary Completion

September 4, 2025

Study Completion

September 4, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)