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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05397041




Registration number
NCT05397041
Ethics application status
Date submitted
19/05/2022
Date registered
31/05/2022
Date last updated
6/07/2023

Titles & IDs
Public title
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of BMB-101 in Fed and Fasted Adult Healthy Human Volunteers
Secondary ID [1] 0 0
PR-BMB-101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMB-101
Treatment: Drugs - Placebo

Experimental: BMB-101 - Participants receiving BMB-101 orally

Placebo Comparator: Placebo - Participants receiving Matched Placebo orally


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

Treatment: Drugs: Placebo
Matched Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Treatment-emergent Adverse Events
Timepoint [1] 0 0
Baseline up to Follow Up/End of Treatment visit, an average of 8 months.
Primary outcome [2] 0 0
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Response
Timepoint [2] 0 0
Administered at each of the following visits in Part 3: Screening, Clinic Discharge, and Follow-up/Early Withdrawal.
Secondary outcome [1] 0 0
Pharmacokinetic Assessment
Timepoint [1] 0 0
Day 1 through End of Dosing Period.

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/05/2023
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bright Minds Biosciences Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05397041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michele De Sciscio
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries