A Phase 1 Study of BLKR201 in Healthy Adult Participants

April 27, 2026 updated by: Formation Bio, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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: BLKR201
BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.
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 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: 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: BLKR201
BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.
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 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: 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: BLKR201
BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline through approximately 7 days after final dose
Treatment-emergent adverse events are defined as adverse events that begin or worsen after administration of BLKR201 or placebo. Events will be summarized by frequency and severity.
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
Clinical laboratory parameters include hematology, clinical chemistry, coagulation, lipid panel, and urinalysis. Change from baseline values will be summarized at scheduled post-dose assessments.
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
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments.
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
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments.
Baseline through approximately 7 days after final dose
Change From Baseline in Pulse Rate
Time Frame: Baseline through approximately 7 days after final dose
Pulse rate will be measured in beats per minute (bpm). Change from baseline will be summarized at scheduled post-dose assessments.
Baseline through approximately 7 days after final dose
Change From Baseline in Respiratory Rate
Time Frame: Baseline through approximately 7 days after final dose
Respiratory rate will be measured in breaths per minute. Change from baseline will be summarized at scheduled post-dose assessments.
Baseline through approximately 7 days after final dose
Change From Baseline in Body Temperature
Time Frame: Baseline through approximately 7 days after final dose
Body temperature will be measured in degrees Fahrenheit (°F). Change from baseline will be summarized at scheduled post-dose assessments.
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
ECG parameters include QT interval corrected using Fridericia's formula (QTcF), PR interval, QRS duration, and heart rate. Change from baseline values will be summarized at scheduled post-dose assessments.
Baseline through approximately 7 days after final dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of BLKR201 After Single Oral Dose
Time Frame: From predose through approximately 7 days after final dose
Cmax is the highest measured plasma concentration of BLKR201 following a single oral dose.
From predose through approximately 7 days after final dose
Area Under the Plasma Concentration-Time Curve (AUC) of BLKR201 After Single Oral Dose
Time Frame: From predose through approximately 7 days after final dose
Area under the plasma concentration-time curve (AUClast and AUCinf) will be calculated using non-compartmental analysis to describe overall drug exposure.
From predose through approximately 7 days after final dose
Maximum Observed Plasma Concentration (Cmax) After Multiple Doses
Time Frame: From predose through approximately 7 days after final dose
Cmax at steady state will be calculated after repeated daily dosing.
From predose through approximately 7 days after final dose
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau) After Multiple Doses
Time Frame: From predose through approximately 7 days after final dose
AUCtau will be calculated to describe total drug exposure during a dosing interval after repeated dosing.
From predose through approximately 7 days after final dose
BLKR201 Concentration in Cerebrospinal Fluid (CSF)
Time Frame: Day 7 post-dose in the CSF cohort (single CSF sampling time point per participant)
BLKR201 concentrations will be measured in cerebrospinal fluid to assess central nervous system exposure.
Day 7 post-dose in the CSF cohort (single CSF sampling time point per participant)
Amount of BLKR201 Excreted in Urine
Time Frame: From predose through 48 hours post-dose (in certain SAD cohorts only)
The amount of BLKR201 excreted in urine will be calculated over defined collection intervals.
From predose through 48 hours post-dose (in certain SAD cohorts only)
Ratio of Maximum Observed Plasma Concentration (Cmax) of BLKR201 Under Fed Versus Fasted Conditions
Time Frame: From predose through 48 hours post-dose (in certain SAD cohorts only)
The ratio of Cmax under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure.
From predose through 48 hours post-dose (in certain SAD cohorts only)
Ratio of Area Under the Plasma Concentration Versus Time Curve (AUC) of BLKR201 Under Fed Versus Fasted Conditions
Time Frame: From predose through 48 hours post-dose (in certain SAD cohorts only)
The ratio of AUC under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure.
From predose through 48 hours post-dose (in certain SAD cohorts only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Formation Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLKR201-101-HV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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