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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BMB-101

• Registration Number: NCT05397041
• Lead Sponsor: Bright Minds Biosciences Pty Ltd

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.

Detailed Description

This study is designed as a 3-part study:

Part 1 is designed as single ascending dose (SAD) escalation study investigating 4 dose levels. Each cohort will consist of participants to be randomly assigned to receive a blinded oral dose of BMB-101 or placebo.

Part 2 is designed as a randomized, orally administered, single-dose, two-treatment (fed vs fasted), two-period, two-sequence crossover to assess the effects of a standard high-fat breakfast on PK of BMB-101.

Part 3 is designed as a multiple ascending dose (MAD) escalation study investigating up to 4 dose levels. Subjects will be randomized to receive double-blind treatment of BMB-101 or matching placebo twice daily for 7 days.

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Study Start: 2022-06-06
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Subject must be aged between 18 and 55 years (both inclusive).
2. Healthy subjects with no clinically significant screening results.
3. Body mass index (BMI) 18.0 to 32.0 kg/m².
4. 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.
5. Agree to frequent blood and urine sampling during the course of the study.
6. Agree to be confined in the study unit and follow study procedures.

Key

Exclusion Criteria

1. 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.
2. 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.
3. Subjects with a history of seizures other than febrile seizures as a child.
4. Subjects with history of or current glucose intolerance; or with history of gestational diabetes.
5. 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)
6. 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.
7. Female subjects with a positive pregnancy test at Screening or Day -1 or who are breastfeeding.
8. 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.
9. Subjects with a positive drug screen for illegal drugs including cannabis at Screening or Day -1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receiving Matched Placebo orally
BMB-101	BMB-101	Participants receiving BMB-101 orally

Primary Outcome Measures

Name	Time	Method
Number of Treatment-emergent Adverse Events	Baseline up to Follow Up/End of Treatment visit, an average of 8 months.	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
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Response	Administered at each of the following visits in Part 3: Screening, Clinic Discharge, and Follow-up/Early Withdrawal.	Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessment	Day 1 through End of Dosing Period.	Concentration of BMB-101 in Plasma and Urine samples: * SAD - 13 blood collection timepoints \& 8 urine PK collection periods over 4 days (Day 1 through End of Dosing period); * FE - 10 blood collection timepoints over 4 days (Day 1 through End of Dosing period) - 20 blood collection timepoints in total as 2 periods in FE; * MAD - 23 blood collection timepoints \& 8 urine PK collection periods over 7 days (Day 1 through End of Dosing period)

Trial Locations

Locations (1)

CMAX Clinical Research; 🇦🇺 Adelaide, South Australia, Australia