Clinical Trial

Dose-Finding Study of NBX-100 in Healthy Adult Participants

Not Yet Recruiting Phase 1
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Record status
This record was last updated February 10, 2026 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
NB-2025 P1 001 is a Phase Ib study that will investigate the pharmacokinetics, pharmacodynamics, safety, tolerability, psychological effects of escalating doses of NBX-100 in healthy volunteers. A 28-day screening period is followed by a preparation visit with psychologist in Week 1. From Week 2 to Week 5, participants will receive a once weekly dose of study treatment, receiving four doses in total. Participants will attend a follow-up visit each day immediately after each dosing day. In Week 6, participants will attend an integration visit with a psychologist, and in Week 10, participants will attend an end-of-study follow-up visit. Participants will have safety, psychological, PK, PD, and pharmacogenomic assessments.
Trial Details
NCT Number NCT07399899
Lead Sponsor Neurala Biosciences
Conditions Healthy Participants
Enrollment 8 participants
Start Date 2026-01-31
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10