EICHORCondition: Healthy · Sponsor: Formation Bio, Inc.
Interested? Contact the study team ↓
The goal of this clinical trial is to learn if BLKR201 is safe in healthy adults. Researchers will also learn how the body absorbs and processes BLKR201 and how food may affect it. The main questions this study aims to answer are: * Is BLKR201 safe and well tolerated when taken as a single dose or for several days in a row? * How does BLKR201 move through and leave the body? * Does taking BLKR201 with food change how the body absorbs it? Researchers will compare BLKR201 to a placebo (a look-alike tablet that contains no drug) in most parts of the study to see how the drug affects participants. Participants will: * Take BLKR201 or a placebo by mouth * Stay at a clinical research unit for several days during dosing * Give blood and urine samples * Have heart tests, vital signs, and lab tests * Report any side effects In one part of the study, a small group of participants will receive BLKR201 only (no placebo). These participants will also have a sample of spinal fluid collected to measure how much BLKR201 reaches the fluid around the brain and spinal cord.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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 * 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 * 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 medical conditions that make a spinal tap unsafe
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Celerion | Lincoln, Nebraska, United States | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07501039