| Eligibility |
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, 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.
|
