Actively Recruiting
A Phase 1 Study of BLKR201 in Healthy Adult Participants
Led by Formation Bio, Inc. · Updated on 2026-04-30
128
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of BLKR201 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men or women aged 18 to 55 years
- Weigh at least 50 kilograms (110 pounds)
- Have a body mass index (BMI) between 18 and 30
- Willing to stay at the research unit for required study visits
- Willing to follow study rules about diet, alcohol, tobacco, and medications
- Able to understand and sign the informed consent form
- Women who can become pregnant must have a negative pregnancy test before starting and use highly effective birth control during the study and after the last dose
- Men with partners who can become pregnant must use highly effective birth control during the study and after the last dose and not donate sperm during that time
You will not qualify if you...
- Have any significant medical condition involving heart, lungs, liver, kidneys, stomach, intestines, brain, blood, or immune system
- Have abnormal laboratory test results at screening deemed important by the study doctor
- Have a history of heart rhythm problems or abnormal ECG results
- Have high blood pressure at screening
- 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 (except certain treated skin cancers)
- Have a history of serious stomach problems such as ulcers, stomach surgery, or 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
- 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
- Regular heavy alcohol use
- Regular use of anti-inflammatory drugs, steroids, or blood thinners
- Donated more than 500 milliliters of blood within 1 month before screening
- For the spinal fluid portion: take blood-thinning medications, have bleeding or clotting problems, or medical conditions making spinal tap unsafe
AI-Screening
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Trial Site Locations
Total: 1 location
1
Celerion
Lincoln, Nebraska, United States, 68502
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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