HealthyPhase 1NCT07501039
A Phase 1 Study of BLKR201 in Healthy Adult Participants
A Phase 1 study testing BLKR201 in people with Healthy, run by Formation Bio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BLKR201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion
Lincoln, Nebraska, 68502
Director, 402-437-4978, brandon.lester@celerion.com
About this study
Official title: 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:
Read more
- 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
- Being tested
- BLKR201, Placebo
- Keywords
- Healthy, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLKR201Drug
BLKR201 is administered orally as a single ascending dose in the SAD stage, under fasted or fed conditions.
BLKR201Drug
BLKR201 is administered orally once daily (QD) or twice daily (BID), under fasted or fed conditions, for 7 consecutive days in the MAD stage.
BLKR201Drug
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.
PlaceboDrug
A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) | Experimental | 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. Receives: Drug: BLKR201; Drug: Placebo |
| Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo) | Experimental | 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. Receives: Drug: BLKR201; Drug: Placebo |
| Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label) | Experimental | 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. Receives: Drug: BLKR201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters include hematology, clinical chemistry, coagulation, lipid panel, and urinalysis. Change from baseline values will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Pulse Rate
Pulse rate will be measured in beats per minute (bpm). Change from baseline will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Respiratory Rate
Respiratory rate will be measured in breaths per minute. Change from baseline will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in Body Temperature
Body temperature will be measured in degrees Fahrenheit (°F). Change from baseline will be summarized at scheduled post-dose assessments.
Measured: Baseline through approximately 7 days after final dose
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
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.
Measured: Baseline through approximately 7 days after final dose
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax) of BLKR201 After Single Oral Dose
Cmax is the highest measured plasma concentration of BLKR201 following a single oral dose.
Measured: From predose through approximately 7 days after final dose
Area Under the Plasma Concentration-Time Curve (AUC) of BLKR201 After Single Oral Dose
Area under the plasma concentration-time curve (AUClast and AUCinf) will be calculated using non-compartmental analysis to describe overall drug exposure.
Measured: From predose through approximately 7 days after final dose
Maximum Observed Plasma Concentration (Cmax) After Multiple Doses
Cmax at steady state will be calculated after repeated dosing.
Measured: From predose through approximately 7 days after final dose
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau) After Multiple Doses
AUCtau will be calculated to describe total drug exposure during a dosing interval after repeated dosing.
Measured: From predose through approximately 7 days after final dose
BLKR201 Concentration in Cerebrospinal Fluid (CSF)
BLKR201 concentrations will be measured in cerebrospinal fluid to assess central nervous system exposure.
Measured: Day 10 post-dose in the CSF cohort (single CSF sampling time point per participant)
Amount of BLKR201 Excreted in Urine
The amount of BLKR201 excreted in urine will be calculated over defined collection intervals.
Measured: 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
The ratio of Cmax under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure.
Measured: 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
The ratio of AUC under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure.
Measured: From predose through 48 hours post-dose (in certain SAD cohorts only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start27 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Formation Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501039
- Sponsor's protocol ID
- BLKR201-101-HV
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07501039
- Acronym / sponsor ID
- BLKR201-101-HV
- Conditions
- Healthy
- Keywords
- Healthy, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Formation Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) | Experimental | Drug: BLKR201, Drug: PlaceboParticipants 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. |
| Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo) | Experimental | Drug: BLKR201, Drug: PlaceboParticipants 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. |
| Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label) | Experimental | Drug: BLKR201Participants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLKR201BLKR201 is administered orally as a single ascending dose in the SAD stage, under fasted or fed conditions. | Drug | Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) |
| BLKR201BLKR201 is administered orally once daily (QD) or twice daily (BID), under fasted or fed conditions, for 7 consecutive days in the MAD stage. | Drug | Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo) |
| BLKR201BLKR201 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. | Drug | Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label) |
| PlaceboA matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort. | Drug | Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo), Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of BLKR201 After Single Oral Dose
Time frame: 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
Maximum Observed Plasma Concentration (Cmax) After Multiple Doses
Time frame: 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
BLKR201 Concentration in Cerebrospinal Fluid (CSF)
Time frame: Day 10 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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLKR201 in people with Healthy, run by Formation Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through approximately 7 days after final dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.