A Phase 1 Study of BLKR201 in Healthy Adult Participants

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Formation Bio, Inc.
Study ID
NCT07501039
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BLKR201 — DRUG
    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.
  • BLKR201 — DRUG
    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.
  • BLKR201 — DRUG
    BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings.
  • Placebo — DRUG
    A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort.

Study Details

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.

Key Dates

Start date
Apr 27, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Single 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.
  • Experimental: Multiple 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.
  • Experimental: Cerebrospinal 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.

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through approximately 7 days after final dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionLincolnNebraska68502
Director
[email protected]
402-437-4978

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Celerion· Lincoln, NE

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