A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers

NCT05397041 | Completed Phase 1

• 1 other identifier: PR-BMB-101-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a single centre, double blind, placebo controlled, randomized, SAD/FE/MAD, safety, tolerance and PK study of BMB-101 in healthy adult subjects. The study will be conducted as a 3-part study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Treatment-emergent Adverse Events

  Incidence and severity of adverse events, including serious adverse events and adverse events, clinically significant changes in laboratory testing, vital signs, Holter monitoring, physical examination, and ECGs

  Baseline up to Follow Up/End of Treatment visit, an average of 8 months.

• Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Response

  Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior

  Administered at each of the following visits in Part 3: Screening, Clinic Discharge, and Follow-up/Early Withdrawal.

Secondary Outcomes (1)

• Pharmacokinetic Assessment

  Day 1 through End of Dosing Period.

Study Arms (2)

BMB-101

EXPERIMENTAL

Participants receiving BMB-101 orally

Drug: BMB-101

Placebo

PLACEBO COMPARATOR

Participants receiving Matched Placebo orally

Drug: Placebo

Interventions

BMB-101 DRUG

Participants will receive one of several different oral doses of BMB-101 once or twice daily

BMB-101

Placebo DRUG

Matched Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be aged between 18 and 55 years (both inclusive).
• Healthy subjects with no clinically significant screening results.
• Body mass index (BMI) 18.0 to 32.0 kg/m².
• Males and non pregnant females willing to use contraceptives consistent with local regulations from screening through 3 months after the last dose of study medication.
• Agree to frequent blood and urine sampling during the course of the study.
• Agree to be confined in the study unit and follow study procedures.

You may not qualify if:

• Subjects with unstable or severe illness as indicated on medical history, physical examination, or clinical laboratory, vital signs, and electrocardiograms (ECGs) evaluations, or in the opinion of the Investigator.
• Subjects with reported history within past 6 months of, or current treatment for, any GI disease that may impact the absorption of an oral drug for example gastroesophageal reflux disorder, peptic ulcer disease, inflammatory bowel disease.
• Subjects with a history of seizures other than febrile seizures as a child.
• Subjects with history of or current glucose intolerance; or with history of gestational diabetes.
• Subjects with lifetime history of suicidal behavior or with lifetime history of suicidal ideation as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Subjects with any use of or intent to use any medications, including prescription, over-the-counter (OTC), herbal preparations, or vitamin/mineral supplementation, other than study medications, from 7 days prior to first dose through follow-up visit.
• Female subjects with a positive pregnancy test at Screening or Day -1 or who are breastfeeding.
• Subjects who have used more than 5 cigarettes, cigars, or nicotine-containing products per month within 6 months prior to first study dose, or plan to use them through completion of the follow-up visit.
• Subjects with a positive drug screen for illegal drugs including cannabis at Screening or Day -1.

Sponsors & Collaborators

• Bright Minds Biosciences Pty Ltd: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Michele De Sciscio

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD, FE, MAD, dose escalating

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: June 6, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)