This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans. Healthy adult men aged 18 to 65 years who meet the study eligibility criteria. Study details Participants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160. Participants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body. There is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.
This study evaluates the safety, tolerability, and pharmacokinetics of SCB0020160 or placebo following single and multiple oral doses in healthy adult male subjects. A total of 74 subjects were planned, including 64 target subjects (8 per dose group) and 10 substitute subjects. The study may be completed without enrolling substitute subjects if all 64 target subjects complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Single and multiple oral doses of SCB0020160 administered under fasting conditions. A food-effect evaluation following a single oral dose will be conducted in Part A Cohort 4.
Matching placebo administered orally under the same dosing conditions as SCB0020160, including participation in the food-effect evaluation in Part A Cohort 4
CMAX Clinical Research Pty Ltd Ground Floor, 21-24 North Terrace
Adelaide, South Australia, Australia
Incidence and frequency of adverse events, adverse drug reactions, serious adverse events, and serious adverse drug reactions
Adverse event analysis will be conducted on Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate General Appearance
For General Appearance assessments are: Level of consciousness (alert, oriented) Nutritional status (well/poorly nourished) Build and posture Signs of distress (pain, dyspnea, fatigue) Hygiene and grooming
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate HEENT
For HEENT assessments are: Head: shape, scalp lesions Eyes: pupil size/reactivity (PERRLA), vision, conjunctiva (pallor/icterus) Ears: hearing, discharge Nose: obstruction, discharge Throat: oral mucosa, tonsils, pharynx
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Neck (incl Thyroid & Nodes)
for Neck (incl Thyroid \& Nodes) assessment are: Thyroid size, nodules, tenderness Cervical lymphadenopathy Neck mobility Jugular venous pressure (if relevant
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Cardiovascular
For Cardiovascular assessment are: Heart rate and rhythm Heart sounds (S1, S2, murmurs) Peripheral pulses Edema (peripheral) Blood pressure
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Respiratory
For Respiratory assessment are: Respiratory rate and effort Chest expansion symmetry Breath sounds (normal, wheeze, crackles) Use of accessory muscles
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Gastrointestinal
For Gastrointestinal assessment are: Abdominal inspection (distension, scars) Palpation (tenderness, masses, organomegaly) Percussion (fluid, liver span) Bowel sounds
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Renal
For Renal assessment are: Flank tenderness (costovertebral angle) Bladder distension Urinary symptoms
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Neurological
For Neurological assessment are: Mental status (orientation, cognition) Cranial nerves (if detailed exam required) Motor function (strength, tone) Sensory function Reflexes Coordination and gait
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Musculoskeletal
For Musculoskeletal assessment are: Joint range of motion Swelling or deformities Muscle strength Tenderness
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Physical examination to evaluate Skin
For Skin assessment are: Color (pallor, cyanosis, jaundice) Rashes or lesions Texture and turgor Ulcers or scars
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Vital signs (body temperature (tympanic)
For body temperature (tympanic) the measurement of unit is degree Celsius
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Vital signs (Pulse Rate)
For Pulse Rate the measurement of unit is - beats/min
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Vital signs (Systolic/Diastolic blood pressure)
For Systolic/Diastolic blood pressure the measurement of unit is - mmHg
Time frame: From first dose through Post-Study Visit (up to Day 33)
For 12-lead ECG (electrocardiogram)
The investigator evaluates heart rate (rate and regularity), waveform shape, and overall rhythm; QTcF (msec) is used in the screening criteria will be collectively assessed
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Clinical Laboratory Test which includes Urinalysis
For Urinalysis - Dipstick + microscopy
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Clinical Laboratory Test which includes the Coagulation
For Coagulation - Prothrombin Time (PT) (INR), Activated Partial Thromboplastin Time (aPTT)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Clinical Laboratory Test which includes the Blood chemistry
For Blood chemistry the test performed will be Calcium, phosphate, glucose, urate, cholesterol, total protein, albumin, total bilirubin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (γ-GT), Creatine Phosphokinase (CPK), Urea, Lactate Dehydrogenase (LDH), creatinine, Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI), sodium, potassium, chloride, triglyceride, Low-Density Lipoprotein Cholesterol (LDL) \& High-Density Lipoprotein Cholesterol (HDL)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Clinical Laboratory Test which includes the Hematology
For Hematology the test performed will be white blood cells with differential, Red blood cells, hemoglobin, hematocrit \& platelet
Time frame: From first dose through Post-Study Visit (up to Day 33)
Pharmacokinetic Parameters of SCB0020160 for Cmax
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for Tmax
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for AUClast
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for AUCinf
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for t½
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for CL/F
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for Vz/F
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Pharmacokinetic Parameters of SCB0020160 for MRT
The results of the outcome are collectively measured
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Comparison of pharmacokinetic parameters for Cmax of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for Tmax of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for Tlag of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for AUClast of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for AUCinf of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for MRT of SCB0020160 under fasting and fed conditions following a single oral dose.
The results of the outcome are collectively measured
Time frame: Up to Day 29.
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