Recruiting
Phase 1
A Phase 1 Study of BLKR201 in Healthy Adult Participants
Condition(s) studied
Healthy
Investigational drug(s) / intervention(s)
BLKR201BLKR201BLKR201Placebo
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.
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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 Parameters — 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 — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Celerion |
Lincoln |
Nebraska |
Recruiting |
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