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

Sponsor

Bright Minds Biosciences Pty Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05397041

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BMB-101 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

SAD, FE, MAD, dose escalatingSAD, FE, MAD, dose escalating

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

Dec 21, 2022

Anticipated Study Completion Date :

Dec 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMB-101 Participants receiving BMB-101 orally	Drug: BMB-101 Participants will receive one of several different oral doses of BMB-101 once or twice daily
Placebo Comparator: Placebo Participants receiving Matched Placebo orally	Drug: Placebo Matched Placebo

Arm

Intervention/Treatment

Experimental: BMB-101

Participants receiving BMB-101 orally

Drug: BMB-101

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

Placebo Comparator: Placebo

Participants receiving Matched Placebo orally

Drug: Placebo

Matched Placebo

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX Clinical Research	Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

Bright Minds Biosciences Pty Ltd

Investigators

Principal Investigator: Michele De Sciscio, CMAX Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bright Minds Biosciences Pty Ltd

ClinicalTrials.gov Identifier:

NCT05397041

Other Study ID Numbers:

PR-BMB-101-101

First Posted:

May 31, 2022

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 10, 2022