Recruiting
Phase 1

BLKR201

Sponsor:

Formation Bio, Inc.

Code:

NCT07501039

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

BLKR201

BLKR201

BLKR201

Placebo

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07501039

Start date

Apr 27, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 kg/m2 (inclusive)
  • 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, or show evidence of hepatitis B infection (positive hepatitis B surface antigen or hepatitis B core antibody). Note: participants with hepatitis B immunity from vaccination alone may still be eligible.
  • 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 sensitivity to lidocaine, band aids, adhesive dressing, or medical tape
  • Have medical conditions that make a spinal tap unsafe

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

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 seven escalating doses of BLKR201 to be evaluated). One cohort will receive a second dose under separate fed and fasted dosing periods to evaluate food effect. Participants are randomized within each cohort.

experimental: Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo)

Participants receive BLKR201 or matching placebo orally for 7 consecutive days in sequential dose-escalation cohorts (up to four escalating doses of BLKR201 to be evaluated). Participants are randomized within each cohort.

experimental: Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label)

Participants receive BLKR201 orally for 10 consecutive days. This cohort is non-randomized and open-label. Cerebrospinal fluid samples are collected on Day 10 to evaluate central nervous system exposure.

Interventions

BLKR201

BLKR201 is administered orally as a single ascending dose in the SAD stage, under fasted or fed conditions.

BLKR201

BLKR201 is administered orally once daily (QD) or twice daily (BID), under fasted or fed conditions, for 7 consecutive days in the MAD stage.

BLKR201

BLKR201 is administered orally once daily (QD) or twice daily (BID), under fasted or fed conditions, for 10 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on emerging pharmacokinetic and safety data.

Placebo

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

Primary outcome measure

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Pulse Rate [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Respiratory Rate [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in Body Temperature [ Time Frame: Baseline through approximately 7 days after final dose ]
  • Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters [ Time Frame: Baseline through approximately 7 days after final dose ]

Central Contacts and Locations

Locations

Celerion

Recruiting

Lincoln, Nebraska, United States, 68502

Contacts

Director

402-437-4978brandon.lester@celerion.com

More Information

Sponsor

Formation Bio, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Healthy
  • Healthy Volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Formation Bio, Inc. on 2026-09-02.