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

NCT ID: NCT05397041

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-05-04

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BMB-101

Participants receiving BMB-101 orally

Group Type: EXPERIMENTAL

BMB-101

Intervention Type: DRUG

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

Placebo

Participants receiving Matched Placebo orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched Placebo

Interventions

BMB-101

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

Intervention Type: DRUG

Placebo

Matched Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bright Minds Biosciences Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele De Sciscio

Role: PRINCIPAL_INVESTIGATOR

CMAX Clinical Research

Locations

CMAX Clinical Research

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

PR-BMB-101-101

Identifier Type: -

Identifier Source: org_study_id