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

NCT07682337 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-07-02

No results posted yet for this study

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

Interventions

DRUG

SCB0020160

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • SCBIO Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07682337 on ClinicalTrials.gov