- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05397041
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Christabel Wilson
- Phone Number: +61 418762141
- Email: christabel.wilson@syneoshealth.com
Study Contact Backup
- Name: Jamie Baker
- Phone Number: +61 (0) 499 111 806
- Email: jamie.baker@syneoshealth.com
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMB-101
Participants receiving BMB-101 orally
|
Participants will receive one of several different oral doses of BMB-101 once or twice daily
|
Placebo Comparator: Placebo
Participants receiving Matched Placebo orally
|
Matched Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Treatment-emergent Adverse Events
Time Frame: 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
|
Baseline up to Follow Up/End of Treatment visit, an average of 8 months.
|
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Response
Time Frame: 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
|
Administered at each of the following visits in Part 3: Screening, Clinic Discharge, and Follow-up/Early Withdrawal.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Assessment
Time Frame: Day 1 through End of Dosing Period.
|
Concentration of BMB-101 in Plasma and Urine samples:
|
Day 1 through End of Dosing Period.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michele De Sciscio, CMAX Clinical Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PR-BMB-101-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States