The study is designed to investigate the safety and tolerability of KBL697 in healthy volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis (AD).
This is a randomized double-blind, placebo-controlled, single centre Phase I study. Thirty-six (36) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows: * Part A (Single Ascending Dose (SAD) in healthy subjects) * Part B (Multiple Ascending Doses (MAD) in healthy subjects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Nucleus Network
Melbourne, Victoria, Australia
Safety and tolerability measure through Adverse Events/Serious Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Measurements at Baseline till 28 days
Safety and tolerability measure through Vital Sign
Measured by result of the Vital Sign(blood pressure, heart rate, axillary body temperature, respiratory rate)
Time frame: Measurement at Baseline till 28 days
Safety and tolerability measure through 12-lead ECG
Measured by result of the ECG measurements and findings
Time frame: Measurement at Baseline till 28 days
Safety and tolerability measure through Physical exam
Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic
Time frame: Measurement at Baseline till 28 days
Safety and tolerability measure through Routine Stool Examination
Measured by result of the Bristol Stool Examination, Occult blood, Parasites
Time frame: Measurement at Baseline till 28 days
Safety and tolerability measure through Clinical laboratory results
Measured by clinically significant change from baseline clinical laboratory results
Time frame: Measurement at Baseline till 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part B: 14 days Cohort MAD2: 4,600mg/day of KBL697 Route of Administration: Oral