Not Yet RecruitingPhase 1

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

Australia74 participantsStarted 2026-06-29

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 evaluat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and frequency of adverse events, adverse drug reactions, serious adverse events, and serious adverse drug reactions

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

For Physical examination to evaluate General Appearance

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

For Physical examination to evaluate HEENT

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

For Physical examination to evaluate Neck (incl Thyroid & Nodes)

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

For Physical examination to evaluate Cardiovascular

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

For Physical examination to evaluate Respiratory

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

For Physical examination to evaluate Gastrointestinal

Trial details

NCT IDNCT07682337

SponsorSCBIO Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Dr. Thomas Polasek

+61558162715 Thomas.Polasek@cmax.com.au

View on ClinicalTrials.gov More Solid Tumor trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and frequency of adverse events, adverse drug reactions, serious adverse events, and serious adverse drug reactions

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

For Physical examination to evaluate General Appearance

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

For Physical examination to evaluate HEENT

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

For Physical examination to evaluate Neck (incl Thyroid & Nodes)

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

For Physical examination to evaluate Cardiovascular

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

For Physical examination to evaluate Respiratory

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

For Physical examination to evaluate Gastrointestinal