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

NCT07399899 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: NB-2025 P1 001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Area under the plasma concentration versus time curve (last)

  AUC0-last across 11 timepoints

  Up to 24 hours post-dose

• Area under the plasma concentration versus time curve (zero to infinity)

  AUC0-inf across 11 timepoints

  Up to 24 hours post-dose

• Peak plasma concentration

  Cmax across 11 timepoints

  Up to 24 hours post-dose

• Time to peak drug concentration

  Tmax across 11 timepoints

  Up to 24 hours post-dose

• Elimination half-life

  t1/2 across 11 timepoints

  Up to 24 hours post-dose

• Apparent drug clearance

  C/F across 11 timepoints

  Up to 24 hours post-dose

Secondary Outcomes (10)

• Assessment of AEs

  Baseline, Day 1, Day 2, Day 5, Day 35

• Tolerability of NBX-100

  Day 1, Day 2, Day 5, Day 35

• Use of rescue medications

  Day 1, Day 2

• Change from baseline in diastolic blood pressure

  Baseline, Day 1, Day 2, Day 7, Day 35

• Clinical laboratory blood tests

  Baseline, Day 1, Day 35

Other Outcomes (10)

• Self-reported subjective psychedelic intensity rating, by dose level

  Day 1, Day 2

• Regensburg Insomnia Scale

  Baseline, Day 5, Day 35

• Activity counts or Electrodermal Activity (EDA) level by dose level

  Baseline, Day 1, Day 2

Study Arms (1)

NBX-100

EXPERIMENTAL

NBX-100 oral capsules

Drug: NBX-100

Interventions

NBX-100 DRUG

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

NBX-100

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females between 21-50 years of age (inclusive).
• Able and willing to provide written informed consent prior to the performance of any study-specific procedures.
• Able and willing to comply with all scheduled visits, study treatment, laboratory tests, lifestyle considerations, and other study procedures.
• Has a nominated person to collect them from the study site in the afternoon/evening of each dosing day and then drive them home.
• 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.
• At least 2 prior ayahuasca experiences within the previous 5 years relative to Screening, but none within the last month
• Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and a body weight ≥50 kg.
• Female participants of childbearing potential must have a negative serum pregnancy test at Screening, and a negative urine pregnancy test at Day 1.
• 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:
• The use of a barrier method of contraception (i.e., a condom or diaphragm);
• Established use of oral, injected or implanted hormonal methods of contraception; or
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Or, either of the below:
• Sterilised male partner; or

You may not qualify if:

• 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.
• Family history of psychosis: past or present diagnosis of bipolar disorder type 1 in first degree relative,
• Family history of psychosis: past or present diagnosis of schizophrenia or schizoaffective disorder in first or second degree relative.
• Current suicidality, or history of suicide attempt.
• Cannot tolerate venipuncture.
• Is not a good candidate for cannulation and/or multiple PK blood draws, as determined by the Principal Investigator or delegate.
• Has a known or suspected hypersensitivity or allergic reaction to any of the ingredients of the study medication.
• 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.
• Has taken prescription medication within 30 days prior to first dose of study medication. A washout can be employed.
• 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.
• Regular smoking (no more than 5 cigarettes or equivalent nicotine products including patches and vapes per week on average over the last 6 months) or any other current substance use disorder (alcohol, amphetamine, cocaine, opiates).
• Positive urine drug screen for substances listed on a drug abuse panel (e.g., methamphetamines, cocaine, cannabinoid/THC, phencyclidine, benzodiazepines, amphetamines, methadone, opiates, tricyclic antidepressants, barbiturates, or cotinine). Urine drug screen may be repeated once at the discretion of the Principal Investigator or delegate.
• Serious medical condition including insulin-dependent diabetes or history of hypoglycaemia, seizure disorder or epilepsy, coronary artery disease, heart failure, cancer, history of cerebrovascular event, uncontrolled or medicated adult asthma, hyperthyroidism, cardiovascular conditions: uncontrolled hypertension, angina, TIA, stroke, peripheral or pulmonary vascular disease.
• Impaired liver function (ALT or AST \> 1.5 × upper limit of normal).
• Renal function issues (eGFR \< 60 mL/min/1.73m2, by CKD-EPI equation).

Sponsors & Collaborators

• Neurala Biosciences: lead

Study Sites (1)

CMAX

Adelaide, South Australia, Australia

Location

Central Study Contacts

Jerome Sarris

CONTACT

+6139035 5553; jerome.s@neurala.co

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple Ascending Dose (MAD) study

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: February 10, 2026
• Study Start: January 31, 2026
• Primary Completion: March 31, 2026
• Study Completion: May 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)