Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects

NCT07682337 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SCB0020160-101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Solid Tumor; Obesity; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (27)

• 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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  From first dose through Post-Study Visit (up to Day 33)

• For Clinical Laboratory Test which includes Urinalysis

  For Urinalysis - Dipstick + microscopy

  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)

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  Up to Day 29.

• Comparison of pharmacokinetic parameters for Tmax of SCB0020160 under fasting and fed conditions following a single oral dose.

  Up to Day 29.

• Comparison of pharmacokinetic parameters for Tlag of SCB0020160 under fasting and fed conditions following a single oral dose.

  Up to Day 29.

• Comparison of pharmacokinetic parameters for AUClast of SCB0020160 under fasting and fed conditions following a single oral dose.

  Up to Day 29.

• Comparison of pharmacokinetic parameters for AUCinf of SCB0020160 under fasting and fed conditions following a single oral dose.

  Up to Day 29.

Study Arms (2)

SCB0020160

EXPERIMENTAL

Single and multiple oral doses of SCB0020160

Drug: SCB0020160

Placebo

PLACEBO COMPARATOR

Matching placebo administered under the same dosing conditions

Drug: Placebo

Interventions

SCB0020160 DRUG

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.

SCB0020160

Placebo DRUG

Matching placebo administered orally under the same dosing conditions as SCB0020160, including participation in the food-effect evaluation in Part A Cohort 4

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Healthy Adult Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• SCBIO Inc.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd Ground Floor, 21-24 North Terrace

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Obesity; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Dr. Thomas Polasek

CONTACT

+61558162715; Thomas.Polasek@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: July 2, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)