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Dose-Finding Study of NBX-100 in Healthy Adult Participants | Clinical Trials | Clareo Health

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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

NCT07399899•Neurala Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females between 21-50 years of age (inclusive).
•2. Able and willing to provide written informed consent prior to the performance of any study-specific procedures.
•3. Able and willing to comply with all scheduled visits, study treatment, laboratory tests, lifestyle considerations, and other study procedures.
•4. Has a nominated person to collect them from the study site in the afternoon/evening of each dosing day and then drive them home.
•5. Medically and psychiatrically healthy as judged by the Principal Investigator or delegate based on medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG.
•6. At least 2 prior ayahuasca experiences within the previous 5 years relative to Screening, but none within the last month
•7. Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and a body weight ≥50 kg.
•8. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, and a negative urine pregnancy test at Day 1.
•9. Female participants of childbearing potential must be willing to use two highly-effective methods of contraception simultaneously from date of consent, and for 30 days after the last dose of study intervention, and must not breastfeed for the same period of time. They are not to donate any ova from the date of first dose and for 30 days after the last dose of study intervention. Approved contraception methods are:
•* The use of TWO of the following:
+16 more criteria

Exclusion Criteria

•1. History of psychosis: past or present diagnosis of bipolar disorder type 1 or type 2, schizophrenia, schizoaffective disorder, major depressive disorder, dysthymia, anxiety disorders, and post-traumatic stress disorder.
•2. Family history of psychosis: past or present diagnosis of bipolar disorder type 1 in first degree relative,
•3. Family history of psychosis: past or present diagnosis of schizophrenia or schizoaffective disorder in first or second degree relative.
•4. Current suicidality, or history of suicide attempt.
•5. Cannot tolerate venipuncture.
•6. Is not a good candidate for cannulation and/or multiple PK blood draws, as determined by the Principal Investigator or delegate.
•7. Has a known or suspected hypersensitivity or allergic reaction to any of the ingredients of the study medication.
•8. High-risk alcohol use (defined as more than 10 standard drinks per week on average over the last 3 months) or history of alcohol abuse in the last 2 years.
•9. Has taken prescription medication within 30 days prior to first dose of study medication. A washout can be employed.
•10. Has taken over-the-counter drugs, including dietary supplements, herbal supplements and traditional medicines within 14 days prior to first dose of study medication. A washout can be employed. Permitted medications for use during the study (but not on the treatment day), include the irregular use of non-opiate analgesics, e.g., paracetamol; the oral contraceptive pill; general nutraceuticals, e.g., vitamins.
+13 more criteria

Locations (1)

CMAX

Adelaide, South Australia, Australia

Key Dates

Start Date

January 31, 2026

Primary Completion Date

March 31, 2026

Completion Date

May 30, 2026

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Participants

Interventions

NBX-100

DRUG

Contacts

Jerome Sarris

CONTACT

+6139035 5553 jerome.s@neurala.co

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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