Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000524594
Ethics application status
Approved
Date submitted
27/03/2024
Date registered
26/04/2024
Date last updated
1/06/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety of a Single and Multiple Oral Doses of a Biologic Therapy (MB-001) or placebo in Healthy Human Participants
Scientific 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
Secondary ID [1] 311832 0
MB-001-101
Secondary ID [2] 312005 0
NCT06363383
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 333362 0
Condition category
Condition code
Oral and Gastrointestinal 330046 330046 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MB-001 consists of capsules for oral administration containing 1mg, 10mg or 30mg of drug substance. Drug administration will take place under observation of site staff.

Single Ascending Dose (SAD) Stage in Healthy Participants
A single dose of MB-001 or matching placebo will be administered to up to 5 cohorts at doses of 1mg, 3mg, 10mg, 30mg and 90mg.

Approximately 4 weeks after completion of the SAD stage, the Multiple Ascending Dose Stage will begin once all the SAD data have been analysed. Participants in the SAD stage will not be able to participate in the MAD stage.

Multiple Ascending Dose Stage in Healthy Participants
A single dose of MB-001 or matching placebo will be administered daily for 5 consecutive days to up to 2 cohorts at doses of 20mg and 60mg.
Intervention code [1] 328286 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules of identical size, shape and color containing microcrystalline cellulose pellets
Control group
Placebo

Outcomes
Primary outcome [1] 337808 0
Incidence and severity of adverse events (AEs) such as upper respiratory tract infections
Timepoint [1] 337808 0
from signing the informed consent form until the end of the study (day 28 for the SAD part and day 33 for the MAD part)
Secondary outcome [1] 433372 0
Pharmacokinetic parameters
Timepoint [1] 433372 0
Within 1 hour prior to dosing then at 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, and 96 hours post dosing for the SAD part
Within 1 hour prior to dosing at days 1 and 2, days 5 to 10, day 19, day 26 and day 33 for the MAD part

Eligibility
Key inclusion criteria
1. Written informed consent prior to the conduct of any study-related assessment.
2. Adults aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
3. Body mass index of 18 to 30 kg/m2, inclusive, at Screening.
4. Estimated glomerular filtration rate > 60 mL/min/1.73m2 at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration formula.
5. 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.
6. 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.
7. Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation.
8. 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.
9. 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.
10. 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.
11. Is in good health based on medical history, physical examination, vital signs measurements, safety laboratory tests, and electrocardiograms (ECGs) performed at screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has any condition that places the participant at significantly increased risk or may compromise the study objectives.
2. 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.
3. 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).
4. 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.
5. 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.
6. Females who are pregnant or lactating.
7. For participants of childbearing potential, has a positive pregnancy test at screening or Day -1.
8. 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).
9. 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).
10. Has alanine transaminase or aspartate transaminase levels > 1.5 x upper limit of normal (ULN) at screening or Day -1.
11. 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.
12. 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, a-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the Investigator.
13. Has known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
14. 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.
15. Has had symptomatic herpes zoster within 3 months prior to first dose of study drug.
16. Has evidence of active or latent tuberculosis (TB) at screening, as documented by QuantiFERON® TB Gold Plus test.
17. 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.
18. Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
19. 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.
20. 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).
21. 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).
22. Has a sensitivity to heparin or history of heparin-induced thrombocytopenia.
23. Has a clinically significant infection requiring the use of oral or intravenous anti-infective therapy within 30 days prior to screening.
24. Has abnormal blood pressure, as determined by the Investigator, at screening or Day -1.
25. Has a clinically significant medical condition that, in the investigator’s opinion, would preclude participation in the study.
26. 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.
27. Has a positive alcohol breath test at screening or Day -1.
28. Has had prior exposure to MB-001.
29. 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.
30. Has consumed any prescription or over-the-counter medication or herbal/vitamin supplement within
30 days prior to first dose of study drug.
31. Participation in strenuous exercise within 3 days prior to first dose of study drug.
32. 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.
33. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/05/2024
Actual
9/05/2024
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
48
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316176 0
Commercial sector/Industry
Name [1] 316176 0
Mage Biologics
Country [1] 316176 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mage Biologics
Address
Country
United States of America
Secondary sponsor category [1] 318358 0
None
Name [1] 318358 0
None
Address [1] 318358 0
Country [1] 318358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314998 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 314998 0
https://bellberry.com.au/
Ethics committee country [1] 314998 0
Australia
Date submitted for ethics approval [1] 314998 0
03/01/2024
Approval date [1] 314998 0
15/03/2024
Ethics approval number [1] 314998 0

Summary
Brief summary
This is a first-in-human, single-ascending and multiple-ascending dose study. Products with the same mode of action are approved in the form of intravenous infusions. The study drug was designed for local release in the colon. The purpose of the study is to assess the safety profile of this new drug in comparison to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133370 0
Dr Alex Choo
Address 133370 0
CMAX, Ground Floor, 21-24 North Terrace Adelaide South Australia 5000
Country 133370 0
Australia
Phone 133370 0
+61 431084977
Fax 133370 0
Email 133370 0
alex.choo@cmax.com.au
Contact person for public queries
Name 133371 0
Kylah Jones
Address 133371 0
Alimentiv BV, Hullenbergweg 278-308, 1101 BV Amsterdam
Country 133371 0
Netherlands
Phone 133371 0
+31657808487
Fax 133371 0
Email 133371 0
MB-001-101-CSM@alimentiv.com
Contact person for scientific queries
Name 133372 0
Kylah Jones
Address 133372 0
Alimentiv BV, Hullenbergweg 278-308, 1101 BV Amsterdam
Country 133372 0
Netherlands
Phone 133372 0
+31657808487
Fax 133372 0
Email 133372 0
MB-001-101-CSM@alimentiv.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not customary for a Phase 1 study in healthy participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.