Solid TumorPhase 1NCT07682337
Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects
A Phase 1 study testing SCB0020160 in people with Solid Tumor and Obesity, run by SCBIO Inc. at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Obesity, Idiopathic Pulmonary Fibrosis
- What is being tested?
- SCB0020160
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Jun 2026to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it
Who cannot join
- 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
- Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening
- Systolic blood pressure more than 80 millimeters of mercury or greater than or equal to140 mmHg
Show all 36Show fewer
- Diastolic blood pressure less than 45 millimeters of mercury or greater than or equal to140 mmHg 90 millimeters of mercury
- Pulse rate less than 45 beats/min or > 105 beats/min
- Has any of the following results in the 12-lead electrocardiogram measured in a semi-supine position after resting for at least 5 minutes at screening, or has clinically significant rhythm findings
- QTcF less than 450 msec
- Has any of the following results in the screening clinical laboratory tests
- Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI equation) < 90 mL/min/1.73 m²
- Fasting serum glucose more than 5.4 millimoles per liter. or less than 3.0 millimoles per liter.
- AST or ALT 1.5 X the upper limit of normal (ULN)
- Total cholesterol less than 5.5 millimoles per liter
- Triglyceride less than 2.0 millimoles per liter.
- Drinks alcohol persistently (less than 21 units/week, 1 unit = 10 gram = 12.5 milli liter of pure alcohol) or is unable to refrain from alcohol consumption from 3 days prior to the expected first dose of the investigational product until the end of the study
- Tested positive for the breath alcohol test at screening or at check-in on D-1 10) Smokers (However, those who quit smoking 3 months prior to the expected first dose of the investigational product may be eligible as subjects)
- Tested positive for the urine cotinine test at screening or at check-in on D-1, even if they do not smoke
- Has taken any prescribed drugs or herbal medicines within 2 weeks prior to the expected first dose, or has taken any over-the-counter (OTC) drugs, health functional foods including liver supplements, or vitamins within 1 week (However, they may participate in the study if the investigator deems their other conditions appropriate), or is expected to take any of the said agents
- Has taken drugs that induce drug-metabolizing enzymes, such as barbiturates, or drugs that inhibit drug metabolism, such as clarithromycin, within 1 month prior to the expected first dose
- Has a history of alcohol or drug abuse, or has shown a positive result for abused drugs in a urine drug test at screening or at check-in on D-1
- Has participated in another study (including bioequivalence studies) and received an investigational product within 3 months prior to the first dose
- Has donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the expected first dose
- Has persistently consumed excessive amounts of caffeine (> 5 units/day, 1 unit = 80 mg of caffeine), or is unable to refrain from consuming caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, health tonics, energy drinks, etc.) from 3 days prior to the expected first dose of the investigational product until the end of the study
- Has consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the expected first dose of the investigational product until the end of the study, or is unable to refrain from consuming grapefruit-containing foods during this period
- Has unusual eating habits (e.g., consuming more than 1L of grapefruit juice per day) or is unable to consume the standard diet provided by the study site during the inpatient period
- Tested positive for serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- Subjects who, or whose spouse (or partner) is a woman of childbearing potential, are unable or unwilling to use methods of contraception considered highly effective for the entire period of the study and for at least 90 days after the last dose of the investigational product, and who do not agree to avoid donating sperm/eggs during this period.
- [Methods of contraception considered highly effective]
- Intrauterine devices and intrauterine hormone-releasing systems with a proven contraception failure rate (< 1%/year) plus the use of a male condom
- Bilateral tubal occlusion or bilateral tubal ligation plus the use of a male condom
- Azoospermia is confirmed by sperm test after vasectomy
- Hormonal contraception (e.g., combined oral contraceptive, progestogen-only oral contraceptive), contraceptive patch, vaginal ring, injection, subdermal contraceptive implant); however, hormonal contraception is limited to cases where it is being used for 28 days or longer prior to the administration of the investigational product and can be continuously used during the study period and up to 90 days after the last dose plus the use of a male condom.
- Sexual abstinence, if it is the usual and preferred method of contraception.
- Those judged by the principal investigator or delegate to be ineligible for participation in the study for reasons other than the above-mentioned criteria (non-compliance with instructions, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
CMAX Clinical Research Pty Ltd Ground Floor, 21-24 North Terrace
Adelaide, South Australia, 5000
About this study
Official title: A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Solid Tumor, Obesity, Idiopathic Pulmonary Fibrosis
- Being tested
- SCB0020160, Placebo
- Medical subject headings
- Obesity, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB0020160Drug
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.
PlaceboDrug
Matching placebo administered orally under the same dosing conditions as SCB0020160, including participation in the food-effect evaluation in Part A Cohort 4
| Study group | Role | What they receive |
|---|---|---|
| SCB0020160 | Experimental | Single and multiple oral doses of SCB0020160 Receives: Drug: SCB0020160 |
| Placebo | Placebo comparator | Matching placebo administered under the same dosing conditions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From first dose through Post-Study Visit (up to Day 33)
For Clinical Laboratory Test which includes Urinalysis
For Urinalysis - Dipstick + microscopy
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 29.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start29 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCBIO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682337
- Sponsor's protocol ID
- SCB0020160-101
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07682337
- Acronym / sponsor ID
- SCB0020160-101
- Conditions
- Solid Tumor, Obesity, Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- SCBIO Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCB0020160 | Experimental | Drug: SCB0020160Single and multiple oral doses of SCB0020160 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered under the same dosing conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
- Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it
Key exclusion criteria (36 listed)
- 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
- Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCB0020160Single 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. | Drug | SCB0020160 |
| PlaceboMatching placebo administered orally under the same dosing conditions as SCB0020160, including participation in the food-effect evaluation in Part A Cohort 4 | Drug | Placebo |
Primary outcome
Incidence and frequency of adverse events, adverse drug reactions, serious adverse events, and serious adverse drug reactions
Time frame: From first dose through Post-Study Visit (up to Day 33)
Adverse event analysis will be conducted on Treatment Emergent Adverse Events (TEAEs)
For Physical examination to evaluate General Appearance
Time frame: From first dose through Post-Study Visit (up to Day 33)
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
For Physical examination to evaluate HEENT
Time frame: From first dose through Post-Study Visit (up to Day 33)
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
For Physical examination to evaluate Neck (incl Thyroid & Nodes)
Time frame: From first dose through Post-Study Visit (up to Day 33)
for Neck (incl Thyroid \& Nodes) assessment are: Thyroid size, nodules, tenderness Cervical lymphadenopathy Neck mobility Jugular venous pressure (if relevant
For Physical examination to evaluate Cardiovascular
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Cardiovascular assessment are: Heart rate and rhythm Heart sounds (S1, S2, murmurs) Peripheral pulses Edema (peripheral) Blood pressure
For Physical examination to evaluate Respiratory
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Respiratory assessment are: Respiratory rate and effort Chest expansion symmetry Breath sounds (normal, wheeze, crackles) Use of accessory muscles
For Physical examination to evaluate Gastrointestinal
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Gastrointestinal assessment are: Abdominal inspection (distension, scars) Palpation (tenderness, masses, organomegaly) Percussion (fluid, liver span) Bowel sounds
For Physical examination to evaluate Renal
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Renal assessment are: Flank tenderness (costovertebral angle) Bladder distension Urinary symptoms
For Physical examination to evaluate Neurological
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Neurological assessment are: Mental status (orientation, cognition) Cranial nerves (if detailed exam required) Motor function (strength, tone) Sensory function Reflexes Coordination and gait
For Physical examination to evaluate Musculoskeletal
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Musculoskeletal assessment are: Joint range of motion Swelling or deformities Muscle strength Tenderness
For Physical examination to evaluate Skin
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Skin assessment are: Color (pallor, cyanosis, jaundice) Rashes or lesions Texture and turgor Ulcers or scars
For Vital signs (body temperature (tympanic)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For body temperature (tympanic) the measurement of unit is degree Celsius
For Vital signs (Pulse Rate)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Pulse Rate the measurement of unit is - beats/min
For Vital signs (Systolic/Diastolic blood pressure)
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Systolic/Diastolic blood pressure the measurement of unit is - mmHg
For 12-lead ECG (electrocardiogram)
Time frame: From first dose through Post-Study Visit (up to Day 33)
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
For Clinical Laboratory Test which includes Urinalysis
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Urinalysis - Dipstick + microscopy
For Clinical Laboratory Test which includes the Coagulation
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Coagulation - Prothrombin Time (PT) (INR), Activated Partial Thromboplastin Time (aPTT)
For Clinical Laboratory Test which includes the Blood chemistry
Time frame: From first dose through Post-Study Visit (up to Day 33)
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)
For Clinical Laboratory Test which includes the Hematology
Time frame: From first dose through Post-Study Visit (up to Day 33)
For Hematology the test performed will be white blood cells with differential, Red blood cells, hemoglobin, hematocrit \& platelet
Pharmacokinetic Parameters of SCB0020160 for Cmax
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for Tmax
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for AUClast
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for AUCinf
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for t½
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for CL/F
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for Vz/F
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
Pharmacokinetic Parameters of SCB0020160 for MRT
Time frame: Up to Day 8 (Part A), Up to Day 21 (Part B), and Up to Day 29 for the Food Effect Cohort
The results of the outcome are collectively measured
6 secondary outcomes
Comparison of pharmacokinetic parameters for Cmax of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for Tmax of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for Tlag of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for AUClast of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for AUCinf of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Comparison of pharmacokinetic parameters for MRT of SCB0020160 under fasting and fed conditions following a single oral dose.
Time frame: Up to Day 29.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCB0020160 in people with Solid Tumor and Obesity, run by SCBIO Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Thomas Polasek (+61558162715, Thomas.Polasek@cmax.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of adverse events, adverse drug reactions, serious adverse events, and serious adverse drug reactions (time frame: From first dose through Post-Study Visit (up to Day 33)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.