Ulcerative ColitisPhase 1NCT06363383
A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants
A Phase 1 study testing MB-001 in people with Ulcerative Colitis, run by Mage Biologics at 1 site in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- MB-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 9 May 2024to 4 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent prior to the conduct of any study-related assessment.
- Adults aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
- Body mass index of 18 to 30 kg/m2 , inclusive, at Screening.
- Estimated glomerular filtration rate > 60 mL/min/1.73m2 at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
- Participants of childbearing potential, fertile male participants, and the female partners of childbearing potential of fertile male participants, must agree to abstain from sexual intercourse or must agree to use highly effective or acceptable methods of contraception from the first dose of study drug until 28 days after the last dose of study drug.
- Agrees not to donate sperm or ova from first dose of study drug until 90 days or 30 days, respectively, after the last dose of study drug.
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- Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation.
- Agrees not to smoke, vape, or consume tobacco or other nicotine-containing products, from screening until the end of study participation. This includes the use of nicotine patches.
- Agrees not to consume alcohol from 3 days prior to first dose of study drug until the end of the in-house portion of study participation.
- Agrees not to consume products containing caffeine or other xanthines from 2 days prior to first dose of study drug until the end of the in-house portion of study participation.
- Is in good health based on medical history, physical examination, vital signs measurements, safety laboratory tests, and electrocardiograms (ECGs) performed at screening.
Who cannot join
- Has any condition that places the participant at significantly increased risk or may compromise the study objectives.
- Is mentally or legally incapacitated, at screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder that would impact study conduct.
- Has a history of lymphoma, leukemia, or any malignant neoplasms or carcinoma in situ within 5 years prior to screening (except successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
- Regularly consumes more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint [473 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit) within 1 month prior to screening.
- Has a history of drug or alcohol abuse (defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) within 3 months prior to screening.
- Females who are pregnant or lactating.
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- For participants of childbearing potential, has a positive pregnancy test at screening or Day -1.
- Has a QTc > 450 msec for male participants or > 470 msec for female participants at screening or Day -1. NOTE: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF = QT/(RR^0.33).
- Has any 12-lead ECG finding at screening or prior to first dose of study drug that may, in the opinion of the Investigator, compromise interpretation of ECGs for cardiac safety assessment or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities).
- Has alanine transaminase or aspartate transaminase levels > 1.5 x upper limit of normal (ULN) at screening or Day -1.
- Has total bilirubin > 1.5 x ULN (isolated bilirubin > 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin is < 35%) at screening or Day -1.
- Has a current or chronic history of liver disease. This includes, but is not limited to, hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the Investigator.
- Has known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Has a positive test for the presence of HIV, hepatitis C antibody, hepatitis B surface antigen or hepatitis B core antibody at screening or within 3 months prior to first dose of study drug.
- Has had symptomatic herpes zoster within 3 months prior to first dose of study drug.
- Has evidence of active or latent tuberculosis (TB) at screening, as documented by QuantiFERON® TB Gold Plus test.
- Has received treatment with a live, attenuated vaccine within 4 weeks prior to randomization or anticipation of need for such a vaccine during the study period.
- Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
- Has donated or lost blood or blood products in volumes of 450 mL or more from 30 days prior to first dose of study drug until the end of study participation.
- Has a history of any known relevant allergy/hypersensitivity or intolerance (including allergy or intolerance to the study medication or its excipients, or to other humanized monoclonal antibodies).
- Has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Has a sensitivity to heparin or history of heparin-induced thrombocytopenia.
- Has a clinically significant infection requiring the use of oral or intravenous anti-infective therapy within 30 days prior to screening.
- Has abnormal blood pressure, as determined by the Investigator, at screening or Day -1.
- Has a clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study.
- Has a positive urine drug screen (including methamphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamine) at screening or Day -1. Repeat analyses will be allowed if the investigator suspects that there might be false positive results.
- Has a positive alcohol breath test at screening or Day -1.
- Has had prior exposure to MB-001.
- Has participated in a study of any investigational drug, device, biologic, or other agent within 30 days or 5 half-lives prior to signing the ICF, whichever is longer.
- Has consumed any prescription or over-the-counter medication or herbal/vitamin supplement within 30 days prior to first dose of study drug.
- Participation in strenuous exercise within 3 days prior to first dose of study drug.
- Has any history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities, diseases, or genetic conditions. Participants with a remote history of uncomplicated medical events (e.g., uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled at the discretion of the investigator.
- Has any clinically significant abnormality identified in the physical examination (including vital signs), laboratory testing, or ECG testing at screening or Day -1. Repeat testing of vital signs to confirm the value is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety and Efficacy of MB-001 in Single and Multiple Ascending Doses in Healthy Human 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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis
- Being tested
- MB-001
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-001Biological
Oral, delayed release formulation of a biologic drug
| Study group | Role | What they receive |
|---|---|---|
| MB-001 capsules | Experimental | Hard shell capsules for oral use as a single administration or multiple daily administrations over five consecutive days Receives: Biological: MB-001 |
| Placebo capsules | Placebo comparator | Matching hard shell placebo capsules for oral use as a single administration or multiple daily administrations over five consecutive days Receives: Biological: MB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: up to day 33 post dosing
Clinically significant changes from baseline in ECG parameters
Number of participants with clinically significant changes in ECG parameters
Measured: up to day 33 post dosing
Secondary outcomes (4)
Area under the concentration-time curve
Plasma levels following drug administration will be determined as area under the concentration-time curve
Measured: 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
Measured: 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
Measured: 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
Measured: up to day 33 post dosing in the multiple dose group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start9 May 2024
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-stage, single-center, double-blinded, randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mage Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alimentiv Inc.
- Responsible party
- Sponsor
- Investigators
- Johannes Spleiss, Study chair, Mage Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363383
- Sponsor's protocol ID
- MB-001-101
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Placebo data may be shared based on a scientifically acceptable synopsis if in line with ICF
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety and Efficacy of MB-001 in Single and Multiple Ascending Doses in Healthy Human Participants
- ClinicalTrials.gov ID
- NCT06363383
- Acronym / sponsor ID
- MB-001-101
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mage BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Alimentiv Inc.
- Study start
- 9 May 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two-stage, single-center, double-blinded, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| MB-001 capsules | Experimental | Biological: MB-001Hard shell capsules for oral use as a single administration or multiple daily administrations over five consecutive days |
| Placebo capsules | Placebo comparator | Biological: MB-001Matching hard shell placebo capsules for oral use as a single administration or multiple daily administrations over five consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent prior to the conduct of any study-related assessment.
- Adults aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
- Body mass index of 18 to 30 kg/m2 , inclusive, at Screening.
- Estimated glomerular filtration rate > 60 mL/min/1.73m2 at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
- Participants of childbearing potential, fertile male participants, and the female partners of childbearing potential of fertile male participants, must agree to abstain from sexual intercourse or must agree to use highly effective or acceptable methods of contraception from the first dose of study drug until 28 days after the last dose of study drug.
Key exclusion criteria (33 listed)
- Has any condition that places the participant at significantly increased risk or may compromise the study objectives.
- Is mentally or legally incapacitated, at screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder that would impact study conduct.
- Has a history of lymphoma, leukemia, or any malignant neoplasms or carcinoma in situ within 5 years prior to screening (except successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
- Regularly consumes more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint [473 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit) within 1 month prior to screening.
- Has a history of drug or alcohol abuse (defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) within 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-001Oral, delayed release formulation of a biologic drug | Biological | MB-001 capsules, Placebo capsules |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: up to day 33 post dosing
The rate and severity of adverse events occurring from first administration until completion of the study will be collected
Clinically significant changes from baseline in vital signs
Time frame: up to day 33 post dosing
Number of participants with clinically significant changes from baseline in vital signs
Clinically significant changes from baseline in physical examination findings
Time frame: up to day 33 post dosing
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.
Clinically significant changes from baseline in clinical laboratory assessments
Time frame: up to day 33 post dosing
Number of participants with clinically significant changes in laboratory measurements
Clinically significant changes from baseline in ECG parameters
Time frame: up to day 33 post dosing
Number of participants with clinically significant changes in ECG parameters
4 secondary outcomes
Area under the concentration-time curve
Time frame: up to 28 days post dosing in the single dose group
Maximum plasma concentration
Time frame: up to 28 days post dosing in the single dose group
Time to reach observed maximum plasma concentration after administration
Time frame: up to 28 days post dosing in the single dose group
Trough concentration
Time frame: up to day 33 post dosing in the multiple dose group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No. Placebo data may be shared based on a scientifically acceptable synopsis if in line with ICF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Spleiss study chair
Mage Biologics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB-001 in people with Ulcerative Colitis, run by Mage Biologics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: up to day 33 post dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.