Phase 1 Study of BLKR201 in Healthy Adults
This study is testing a drug called BLKR201 in healthy adults aged 18 to 55. The main goals are to find out if BLKR201 is safe when taken as a single dose or for several days, how your body handles the drug, and if food changes how your body absorbs it. You would receive either BLKR201 or a placebo (a tablet with no drug). Researchers will check for any side effects and changes in your blood pressure and lab results. This study aims to enroll 128 participants.
- Study design
- This is an interventional Phase 1 study comparing BLKR201 to a placebo in healthy adults. It plans to enroll 128 participants.
- What's involved
- You would need to stay at the research unit for required study visits and follow rules about diet, alcohol, tobacco, and medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor you for about 7 days after your last dose for side effects and changes in your health.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study of BLKR201 in Healthy Adult Participants
At a glance
Conditions
NCT07501039
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Celerion
Lincoln, Nebraskastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)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 ParametersBaseline 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 PressureBaseline 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 PressureBaseline 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 RateBaseline 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 RateBaseline 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 TemperatureBaseline 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) ParametersBaseline 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.