A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants
← catalyst calendarNCT07225517 · readout in 166 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
104estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-18 | actual | When the study began enrolling |
| Primary completion | 2027-02-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-02 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Interventions
- Drug: BIIB145
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFParts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
measured Parts A and Part B: Up to Day 14; Part C: Up to Day 28
Parts A, B, and C: Number of Participants With Clinical Laboratory Abnormalities
measured Parts A and Part B: Up to Day 14; Part C: Up to Day 28
Parts A, B, and C: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
measured Parts A and Part B: Up to Day 14; Part C: Up to Day 28
Part C: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events
measured Part C: Up to Day 28
Parts A, B, and C: Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters
measured Parts A and B: Up to Day 14; Part C: Up to Day 28
Permalink · BIIB's whole pipeline · Catalyst calendar · Every registered study · What changed