NCT07501039 A Phase 1 Study of BLKR201 in Healthy Adult Participants
| NCT ID | NCT07501039 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Formation Bio, Inc. |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2026-04-27 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07501039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07501039 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07501039 currently recruiting?
Yes, NCT07501039 is actively recruiting participants. Visit ClinicalTrials.gov or contact Formation Bio, Inc. to inquire about joining.
Where is the NCT07501039 trial being conducted?
This trial is being conducted at Lincoln, United States.
Who is sponsoring the NCT07501039 clinical trial?
NCT07501039 is sponsored by Formation Bio, Inc.. The trial plans to enroll 128 participants.