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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397041
• Other study ID #: PR-BMB-101-101
• Status: Completed
• Phase: Phase 1
• Start date: June 6, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: July 2023
• Source: Bright Minds Biosciences Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BMB-101
Participants will receive one of several different oral doses of BMB-101 once or twice daily
• Placebo
Matched Placebo

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Bright Minds Biosciences Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Pharmacokinetic Assessment	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)	Day 1 through End of Dosing Period.