| Eligibility |
Inclusion Criteria:
- Male or female subjects who, at the time of signing the informed consent form (ICF),
are between 18 and 55 years of age (inclusive).
- The subject is capable of understanding and complying with protocol requirements
- Subjects in good health based on pre-study medical history, physical examinations,
vital signs, abdominal ultrasound, 12-lead ECGs, clinical laboratory tests.
- The subject weighs at least 45 kg and has a body mass index between 18 and 32 kg/m2
(inclusive).
- Must be capable of giving signed informed consent as described which includes
compliance with the requirements and restrictions listed in the ICF and in this
protocol.
- Women not of childbearing potential. OR must agree to use a double barrier highly
effective method of contraception from the beginning of screening until at least 90
days after the last dose of study intervention.
Exclusion Criteria:
- Active or history of serious mental illness or psychiatric disorder, including but not
limited to schizophrenia, bipolar disorder, or major depressive disorder, which
require current medical intervention.
- Subject has abnormal screening or Check-in (D-1) laboratory values that suggest a
clinically significant underlying disease or subject has the following lab
abnormalities: alanine transferase (ALT) and/or aspartate transaminase (AST) >1.5
upper limit of normal (ULN).
- History of autonomic neuropathy, or diabetic neuropathy, or evidence of autonomic
neuropathy, or presence of clinically relevant peripheral neuropathy.
- Resting heart rate of <50 or >100 beats per minute (not on ECG).
- History or evidence at screening of heart block.
- History of myocardial infarction, acute coronary syndromes, or cerebrovascular
accident within 12 months prior to the screening visit.
- Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C positive by
serological testing at the screening visit.
- History or presence of malignancy within 5 years prior to screening, except subjects
who have been treated successfully with no recurrence of basal or squamous cell
carcinoma of the skin (<1 year), in situ cervical cancer, or in situ ductal breast
cancer.
- Women of reproductive potential who have a positive serum pregnancy test result at the
screening visit, or a positive urine pregnancy test result at the baseline visit
(D-1), or who do not have their pregnancy test results on D-1.
- Subject has donated or lost 400 mL or more of his or her blood volume (including
plasmapheresis) or had a transfusion of any blood product within 30 days prior to
first dose of study intervention.
- Clinically significant illness within seven days before the first dose of the study
intervention.
- History of multiple drug allergies or history of allergic reaction to the monoclonal
antibody.
- History of severe intolerance to SC injection (minor reactions are permitted, e.g.,
localized swelling or redness).
- Significant concomitant illness or any medical or surgical condition, such as, but not
limited to, cardiac, renal, neurological, endocrinological, gastrointestinal, hepatic,
metabolic or lymphatic disease that would adversely affect the subject's participation
in this study or interpretation of safety/PK data.
- Dosing with another investigational drug or therapy within 30 days or at least 5
half-lives of the investigational drug, whichever is longer.
- Systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) >90 mmHg
after 5 minutes of resting in a seated position, unless determined by the Investigator
to be not clinically relevant and well controlled with medications.
- Pregnant or breast-feeding women.
- Any conditions which would make the subject unsuitable for enrollment or could
interfere with the subject's participation in or completion of the study in the
opinion of the Investigator.
- Consume more than 14 (female) or 21 (male) units of alcohol per week (unit: 1 glass of
wine (125 mL) = 1 measure of spirits = ½ pint of beer) within the 12 months before
screening or positive screen for alcohol abuse.
- Smoking >4 cigarettes (or an equivalent amount of any other nicotine-containing
product) per day within 30 days before screening.
- History or clinical evidence of drug abuse within the 12 months before screening or
positive screen for drug abuse. Drug abuse is defined as compulsive, repetitive,
and/or chronic use of drugs or other substances with or without problems related to
their use and/or when stopping or a dose reduction will lead to withdrawal symptoms.
- Have received a live and/or non-live vaccine (including COVID) within 28 days prior to
dosing or intend to receive a vaccine during the study period or at least 56 days
after the last dose of IP.
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