NCT07399899

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

A Phase 1, Dose-Escalating Crossover, Pharmacokinetic/Pharmacodynamic Study, Assessing the Safety and Pharmacokinetics of NBX-100 in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Neurala Biosciences · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

NB-2025 P1 001 is a Phase I, single-centre study that will investigate the pharmacokinetics, pharmacodynamics, safety, tolerability, psychological effects of escalating doses of NBX-100 in healthy volunteers. A total of eight (8) participants will be enrolled overall, split into two cohorts of four (4) participants. This split into two cohorts is for logistical purposes, as there is a maximum of four participants allowable per cohort in the facility to provide sufficient safety oversight. Participants will attend the clinic as part of their cohort for individual dosing sessions, with dosing to be performed in separate dosing rooms. Doses for each participant will be staggered per PI discretion, and each participant may be separated into individual dosing rooms to avoid social contagion effects. Doses will be the equivalent of 10, 40, 80 or up to 120 mg of a tryptamine, ascending from 10 mg at Dose 1 to at most 120 mg at Dose 4. The tryptamine will be given in combination with an MAOI-a combination. Following a 28-day Screening period (Day -28 to Day -1), participants will attend a preparation session in Week 1, the week prior the first dosing session, with a clinical psychologist, and be provided with supportive preparation material. In the Week 2 to 5 visits, participants will attend a one-on-one session with a clinical psychologist the night before each dosing day, at the facility, then stay overnight. On each dosing day, participants will be administered a single dose of study treatment (NBX-100 capsules) according to the dosing schedule. Participants will remain at the facility for monitoring and assessment. At the end of the day, after medical assessment and sign off from the Investigator, participants are to be picked up by a nominated person for transport. An overnight stay after the dose is optional, if requested by the study team or the participant. In the event of an adverse event the medical and psychologist team will either have the participant stay overnight, or offer appropriate management strategy if the participant declines to stay. Participants are to return the following day for follow-up assessments. In Week 6, participants are to attend an Integration session with a clinical psychologist. The End-of-Study/Follow-up visit will occur in Week 10.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	NBX-100	NBX-100 comprises of a tryptamine and two other MAOI compounds

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-03-31
• Completion: 2026-05-30
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Australia