A Phase 1 Study of BLKR201 in Healthy Adult Participants

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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