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

Sponsor
SCBIO Inc.
Study ID
NCT07682337
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Idiopathic Pulmonary Fibrosis
  • Obesity
  • Solid Tumor

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Jun 29, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCB0020160
    Single and multiple oral doses of SCB0020160
  • Placebo Comparator: Placebo
    Matching placebo administered under the same dosing conditions

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) ]

Central Contacts

Find similar trials

Nationwide
Obesity / overweight trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies