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

NCT07399899 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

NBX-100

NBX-100 comprises of a tryptamine and two other MAOI compounds

Sponsors & Collaborators

  • Neurala Biosciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-05-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399899 on ClinicalTrials.gov