A Phase 1 Study of BLKR201 in Healthy Adult Participants

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFormation Bio, Inc.

About this trial

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

Qualifiers

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 kg/m2 (inclusive)

Are willing to stay at the research unit for the required study visits

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BLKR201
  • BLKR201
  • BLKR201
  • Placebo

Treatment groups

128 Participants
are divided into 3 treatment groups

Sponsors and collaborators