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A Phase 1 Study of BLKR201 in Healthy Adult Participants Phase 1 128 No Placebo Single Dose
Clinical Trial NCT07501039 is designed to study Other for Healthy. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on May 1, 2026 until the study accrues 128 participants. Led by Formation Bio, Inc., this study is expected to complete by February 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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 h...
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
Conditions
HealthyOther Study IDs
- BLKR201-101-HV
NCT ID Number
Start Date (Actual)
2026-05
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-02
Enrollment (Estimated)
128
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Keywords
Healthy
Healthy Volunteers
Healthy Volunteers
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSingle 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. | 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. Placebo A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort. |
ExperimentalMultiple 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. | 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. Placebo A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort. |
ExperimentalCerebrospinal 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. | BLKR201 BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline through approximately 7 days after final dose |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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 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 | 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) | 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 | 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 | 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 | 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
Formation Bio, Inc.No contact data.
1 Study Locations in 1 Countries
Nebraska
Celerion, Lincoln, Nebraska, 68502, United States
Director, Contact, 402-437-4978, [email protected]