Share
Save
A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants
The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are: Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug. Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose.
Study details:
This is a two-stage, single-center, double-blinded, randomized, placebo-controlled study evaluating the safety ofMB-001 in healthy adult participants. The two stages are:. * A single ascending dose (SAD) stage in healthy participants.
* A multiple ascending dose (MAD) stage in healthy participants. Up to 5 cohorts of healthy adult participants will receive a single oral dose of either MB-001 or placebo. Following a review of all safety data available for the current cohort and any preceding cohorts, the Safety Review Committee (SRC) will decide whether to proceed to the next cohort.
The MAD stage in healthy participants will commence once sufficient safety data are available from the SAD stage, after the completion of all SAD cohorts.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-05-09
Primary completion: 2025-05-01
Study completion finish: 2025-05-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06363383
Intervention or treatment
BIOLOGICAL: MB-001
Conditions
- • Ulcerative Colitis
Find a site
Closest Location:
CMAX
Research sites nearby
Select from list below to view details:
CMAX
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: MB-001 capsules
| BIOLOGICAL: MB-001
|
PLACEBO_COMPARATOR: Placebo capsules
| BIOLOGICAL: MB-001
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence and severity of adverse events (AEs) | The rate and severity of adverse events occurring from first administration until completion of the study will be collected | up to day 33 post dosing |
Clinically significant changes from baseline in vital signs | Number of participants with clinically significant changes from baseline in vital signs | up to day 33 post dosing |
Clinically significant changes from baseline in physical examination findings | At screening, a complete physical examination will be performed and at subsequent visits, a limited, symptom-directed physical examination will be performed. Any abnormality identified will be recorded either as medical history or as an AE accordingly. | up to day 33 post dosing |
Clinically significant changes from baseline in clinical laboratory assessments | Number of participants with clinically significant changes in laboratory measurements | up to day 33 post dosing |
Clinically significant changes from baseline in ECG parameters | Number of participants with clinically significant changes in ECG parameters | up to day 33 post dosing |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Area under the concentration-time curve | Plasma levels following drug administration will be determined as area under the concentration-time curve | up to 28 days post dosing in the single dose group |
Maximum plasma concentration | The maximum plasma concentration reached after drug administration will be determined | up to 28 days post dosing in the single dose group |
Time to reach observed maximum plasma concentration after administration | The time from drug administration until the maximum plasma concentration is reached will be calculated | up to 28 days post dosing in the single dose group |
Trough concentration | The lowest plasma concentrations will be determined after each dosing prior to the next dosing in the multiple dose group | up to day 33 post dosing in the multiple dose group |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!