ACTRN12624000524594
Recruiting
Phase 1
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
Mage Biologics0 sites48 target enrollmentApril 26, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- lcerative colitis
- Sponsor
- Mage Biologics
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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.
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\).
Outcomes
Primary Outcomes
Not specified
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