New drug STAR-0310 put to the test in healthy people
NCT ID NCT06782477
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called STAR-0310 in 40 healthy adults to see if it is safe and how the body processes it. Participants receive either the drug or a placebo, and researchers monitor for side effects. This study does not aim to treat any disease; it is a first step to gather important safety information.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Good health as determined by the Investigator based upon a medical evaluation. * Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant. * Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment * Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation * Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent). Exclusion Criteria: * Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant. * Known sensitivity to the ingredients of STAR-0310 * Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission * History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission * Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Clinical Research Unit - Early Clinical Development
Austin, Texas, 78744, United States
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