Phase 1 test of BLKR201 in healthy adults
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BLKR201 in Healthy Adult Participants
This trial will test whether BLKR201 is safe and how the body absorbs and clears it in healthy adults aged 18 to 55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Formation Bio, Inc. Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT07501039 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 1 trial in healthy volunteers that includes single- and multiple-dose arms and a dedicated food-effect comparison. Participants will take BLKR201 or placebo by mouth, stay at a clinical research unit for several days during dosing, and provide blood and urine samples for pharmacokinetic and safety testing. Safety monitoring includes vital signs, ECGs, lab tests, and collection of reported side effects; a small subgroup will have a spinal fluid sample collected. Results will characterize tolerability, how the drug moves through and leaves the body, and whether food changes absorption.
Who should consider this trial
Good fit: Healthy men and women aged 18–55 years who weigh at least 50 kg, have a BMI of 18–30, can stay at the research unit as required, and agree to required contraception and study rules are ideal candidates.
Not a fit: People with significant medical conditions, abnormal screening labs, pregnant or breastfeeding women, or those outside the age/weight/BMI ranges are not eligible and unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the study could show BLKR201 is safe and has predictable absorption, supporting further testing of the drug in patients with a target condition.
How similar studies have performed: The single- and multiple-dose, placebo-controlled, food-effect design is a well-established approach that has been used successfully in many early-phase drug programs, although BLKR201 itself is a new investigational agent.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lincoln, Nebraska
- Celerion — Lincoln, Nebraska, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.