Dose-Finding Study of NBX-100 in Healthy Adult Participants
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.
Timeline
- Start
- 2026-01-31
- Primary completion
- 2026-03-31
- Completion
- 2026-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NBX-100 | Unknown | 10 mg | Oral |
| Subject | NBX-100 | Unknown | 40 mg | Oral |
| Subject | NBX-100 | Unknown | 80 mg | Oral |
| Subject | NBX-100 | Unknown | 120 mg | Oral |
Indications
No indication recorded.