A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants

NCT06363383 | Completed Phase 1 DMC

• 1 other identifier: MB-001-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Area under the concentration-time curve

  up to 28 days post dosing in the single dose group

• Maximum plasma concentration

  up to 28 days post dosing in the single dose group

• Time to reach observed maximum plasma concentration after administration

  up to 28 days post dosing in the single dose group

• Trough concentration

  up to day 33 post dosing in the multiple dose group

Study Arms (2)

MB-001 capsules

EXPERIMENTAL

Hard shell capsules for oral use as a single administration or multiple daily administrations over five consecutive days

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

Biological: MB-001

Interventions

MB-001 BIOLOGICAL

Oral, delayed release formulation of a biologic drug

MB-001 capsules; Placebo capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mage Biologics: lead
• Alimentiv Inc.: collaborator

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Johannes Spleiss

  Mage Biologics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded using matching placebo capsules containing matching pellets
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-stage, single-center, double-blinded, randomized, placebo-controlled

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 12, 2024
• Study Start: May 9, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)