Status:
COMPLETED
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers
Lead Sponsor:
Bright Minds Biosciences Pty Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
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 assig...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05397041
Start Date
June 6 2022
End Date
May 4 2023
Last Update
July 6 2023
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000