Evaluating the safety of an oral biologic in healthy volunteers

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

This study is testing a new oral medication called MB-001 in healthy adults to see if it's safe to take at different doses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Mage Biologics (Industry-sponsored)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06363383 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety of an oral biologic called MB-001 in healthy adult participants. It consists of two stages: a single ascending dose (SAD) stage and a multiple ascending dose (MAD) stage, where participants will receive either MB-001 or a placebo. The study is designed to monitor side effects and determine the safety profile of the drug at increasing doses. Participants will be closely monitored in a clinical setting for five days following the last dose.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a body mass index between 18 and 30.

Not a fit: Patients with existing health conditions or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a new treatment option for ulcerative colitis.

How similar studies have performed: While this approach is focused on a specific oral biologic, similar studies evaluating the safety of biologics have shown promise in the past.

Eligibility criteria

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.

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, α-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.

Where this trial is running

Adelaide, South Australia

• Cmax — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Kylah Jones

Conditions Ulcerative Colitis