Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-65
SponsorSCBIO Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening
Body weight more Than or equals to 45.0 kilograms per square meter at screening, with a body mass index (BMI) of more than or equals to18.0-kilogram Meter square and less than or equals to 32.0 Kilograms per meter square
Body Mass Index (BMI, kilograms per square meter.) = Weight (kilogram)/[Height square meter]
Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate
Disqualifiers
Has a history of or currently has any disease, including clinically significant hepatobiliary (severe liver impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), neurological, immunological, respiratory, digestive, endocrine, hematologic and oncologic, cardiovascular (Torsades de pointes, etc.), urological, psychiatric (mood disorders, obsessive compulsive disorder, etc.), and sexual function disorders
Has a history of or currently has a gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) that may affect the safety and pharmacokinetic evaluation of the investigational product, or has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery)
Has a history of hypersensitivity to the active pharmaceutical ingredient and components of the investigational product, drugs in the same class as the active pharmaceutical ingredient, or other drugs (aspirin, antibiotics, etc.)
Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
Trial design
Design model
Parallel
Treatments tested in this trial
SCB0020160
DrugSingle 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.
Placebo
DrugMatching placebo administered orally under the same dosing conditions as SCB0020160, including participation in the food-effect evaluation in Part A Cohort 4
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: SCB0020160Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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 29.2
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 29.3
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 29.4
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. Source ClinicalTrials.gov
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