Can a new drug pass early safety tests in humans?
NCT ID NCT07797478
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This early-stage trial tests the safety and how the body processes an experimental drug called RO7890597 in healthy adult volunteers. Participants receive either the drug or a placebo, and the study also looks at how food, stomach acid reducers, and another drug affect its levels in the body. The goal is to gather essential safety and dosing information before the drug can be studied in people with specific conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7890597, an experimental drug, given alone or with other medications to see how the body handles it
- What this could lead to
- If successful, this early study could pave the way for larger trials of RO7890597 as a potential treatment for future conditions.
- What could go wrong
- This is a Phase 1 trial with a small number of healthy volunteers, so results may not predict effects in patients. The drug may cause unexpected side effects or fail to show promise.
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 139 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
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 65 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: * Agreement to adhere to the contraception requirements. * Body mass index of 18 to 30 kilograms per square meter (kg/m²). Exclusion Criteria: * Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period. * Treatment with investigational biologic therapy within 90 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with investigational non-biologic therapy within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with immunosuppressive medication within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with any vaccine within 14 days prior to initiation of study drug, or within 28 days for a live or live attenuated vaccine. * Poor peripheral venous access. * Major surgery within 28 days before study drug initiation or planned major surgery during the study. * Current infection or recent infection requiring antibiotics as defined in the protocol. * History of malignancy within 5 years before screening, except for specified adequately treated cancers. * History of clinically significant drug or food allergy.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ICON (LPRA) - Lenexa
RECRUITINGLenexa, Kansas, 66219, United States
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