RecruitingPhase 1NCT07501039

A Phase 1 Study of BLKR201 in Healthy Adult Participants

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

Sponsor

Formation Bio, Inc.

Enrollment

128 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria12

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 Criteria22

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

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Interventions

DRUGBLKR201

BLKR201 is administered orally as a single ascending dose in the SAD stage. In the food effect cohort, BLKR201 is administered under both fasted and fed conditions in separate periods.

DRUGBLKR201

BLKR201 is administered orally once daily for 7 consecutive days in the MAD stage. A twice-daily schedule may be evaluated in a separate cohort if supported by emerging data.

DRUGBLKR201

BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.

DRUGPlacebo

A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.