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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)
Masking Description
Open-label for CSF cohort only

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) 		Participants receive a single oral dose of BLKR201 or matching placebo in sequential dose-escalation cohorts (up to six escalating doses of BLKR201 to be evaluated) under fasted conditions. One cohort will receive a second dose under fed conditions. Participants are randomized within each cohort.
  • Drug: BLKR201
    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.
  • Drug: Placebo
    A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.
Experimental
Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo) 		Participants receive BLKR201 or matching placebo orally once daily for 7 consecutive days in sequential dose-escalation cohorts (up to four escalating doses of BLKR201 to be evaluated). A twice-daily (BID) cohort may be evaluated based on emerging safety and PK data. Participants are randomized within each cohort.
  • Drug: BLKR201
    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.
  • Drug: Placebo
    A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.
Experimental
Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label) 		Participants receive BLKR201 orally for 7 consecutive days (planned dose: 200 mg once daily). This cohort is non-randomized and open-label. Cerebrospinal fluid samples are collected to evaluate central nervous system exposure.
  • Drug: BLKR201
    BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.

Recruiting Locations

Celerion
Lincoln, Nebraska 68502
Contact:
Director
402-437-4978
brandon.lester@celerion.com

More Details

Status
Recruiting
Sponsor
Formation Bio, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.