The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..
This is a randomized, double-blind, placebo-controlled, single centre Phase I study. Eighteen (18) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows: * Cohort 1: 680 mg/day * Cohort 2: 6800 mg/day
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Linear Clinical Research
Nedlands, Western Australia, 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 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(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
Measured by result of the Vital Sign- blood pressure
Time frame: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate
Measured by result of the Vital Sign- heart rate
Time frame: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature
Measured by result of the Vital Sign- axillary body temperature
Time frame: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate
Measured by result of the Vital Sign- respiratory rate
Time frame: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) 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(Incidence of Treatment-Emergent Adverse Events) 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
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Time frame: Measurement at Baseline till 28 days
Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) 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(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results
Measured by clinically significant change from baseline clinical laboratory results
Time frame: Measurement at Baseline till 28 days
Difference in the change from baseline in profile of faecal KBL693 between treatment arms
Measured by quantitative analysis method for understanding distribution and excretion of KBL693
Time frame: Measurements at Baseline till 28 days