New drug BLKR201 put to the test in healthy volunteers
NCT ID NCT07501039
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This early-stage study is testing whether a new drug called BLKR201 is safe for people. About 128 healthy adults will take either the drug or a placebo and stay at a research clinic for several days. Researchers will monitor side effects, measure how the drug moves through the body, and check if food changes its absorption. This study does not aim to treat any disease.
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 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 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 55 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: * Are a healthy man or woman 18 to 55 years old * Weigh at least 50 kilograms (110 pounds) * Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) * Are willing to stay at the research unit for the required study visits * Are willing to follow study rules about diet, alcohol, tobacco, and medications * Are able to understand and sign the informed consent form Women who can become pregnant must: * Have a negative pregnancy test before starting * Use a highly effective form of birth control during the study and for a period after the last dose Men with partners who can become pregnant must: * Use highly effective birth control during the study and for a period after the last dose * Not donate sperm during that time Exclusion Criteria: * Have any significant medical condition involving the heart, lungs, liver, kidneys, stomach, intestines, brain, blood, or immune system * Have abnormal laboratory test results at screening that the study doctor considers important * Have a history of heart rhythm problems or abnormal electrocardiogram (ECG) results * Have high blood pressure at screening * Have had a serious infection within the past 6 months * Test positive for HIV, hepatitis B, hepatitis C, or tuberculosis, or show evidence of hepatitis B infection (positive hepatitis B surface antigen or hepatitis B core antibody). Note: participants with hepatitis B immunity from vaccination alone may still be eligible. * Have a history of cancer in the past 5 years (with limited exceptions for certain treated skin cancers) * Have a history of serious stomach problems such as ulcers, stomach surgery, or stomach bleeding * Use tobacco, nicotine, or marijuana products * Test positive for drugs or alcohol at screening * Have taken another investigational drug within the required time before this study * Have received a live vaccine within 30 days before study start * Are pregnant or breastfeeding * Have a known allergy to the study drug or similar medicines Additional exclusions: * Regular heavy alcohol use * Regular use of certain medications such as anti-inflammatory drugs, steroids, or blood thinners * Donation of more than 500 milliliters (about one pint) of blood within 1 month before screening For the spinal fluid (CSF) portion of the study, you cannot take part if you: * Take blood-thinning medications * Have bleeding or clotting problems * Have sensitivity to lidocaine, band aids, adhesive dressing, or medical tape * Have medical conditions that make a spinal tap unsafe
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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.
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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Celerion
RECRUITINGLincoln, Nebraska, 68502, United States
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