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NCT07501039 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of BLKR201 in Healthy Adult Participants
A Phase 1 study, sponsored by Formation Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
NCT07501039: Recruiting Phase 1 study, sponsored by Formation Bio.
NCT07501039 is a Phase 1 study that is actively recruiting participants, run by Formation Bio. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07501039, a Phase 1 study, is actively recruiting participants, sponsored by Formation Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG BLKR201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2026-04-27 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT07501039 shows while recruiting
NCT07501039 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07501039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07501039 about?
NCT07501039 is a clinical study titled "A Phase 1 Study of BLKR201 in Healthy Adult Participants". 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...
What is the current status of trial NCT07501039?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2026-04-27. Estimated completion is 2027-02.
What interventions are being tested in trial NCT07501039?
The interventions under investigation include: Placebo (DRUG), BLKR201 (DRUG).
Who is sponsoring clinical trial NCT07501039?
This trial is sponsored by Formation Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07501039's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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