| Eligibility |
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet ALL of the
following criteria:
1. Healthy male and female subjects, 18 to 45 years of age, inclusive.
2. The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs
at least 50 kg.
3. The subject is in good health and has no medical condition of clinical significance or
that may impact the outcome of the study, as determined by the investigator (as
determined by medical history, physical examination, 12-lead electrocardiogram [ECG],
vital signs, and clinical laboratory results at screening).
4. The subject is able to understand the nature of the study and any potential hazards
associated with participating in it.
5. The subject is able to communicate satisfactorily with the investigator and to
participate in, and comply with, the requirements of the study.
6. The subject is willing to provide written informed consent to participate in the study
after reading the informed consent form and the information provided, and has had the
opportunity to discuss the study with the investigator or designee.
7. Negative pregnancy test for female subjects. Women of child bearing potential (WOCBP)
and Women not of child bearing potential are eligible to participate. Both women of
child bearing potential and women of no child bearing potential should use an approved
method of birth control and agrees to continue to use this method for the duration of
the study (and for 90 days after taking the last dose of Progerinin).
Acceptable methods of contraception include abstinence, female subject/partner's use
of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier
method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or
if the female subject/partner is surgically sterile or 2 years post-menopausal. All
male subjects/partners must agree to consistently and correctly use a condom for the
duration of the study and for 90 days after taking the study drug. In addition,
subjects may not donate sperm for the duration of the study and for 90 days after
taking study drug.
8. Subjects not taking any medications or dietary supplements (i.e., St. John's Wort and
goldenseal) which are inhibitors or inducers of CYP 3A4 and CYP 2D6 during screening
and for the duration of the trial.
9. Subjects not taking any medications which are substrates of CYP2C8, CYP2C9, CYP2C19,
CYP2D6, CYP3A4/5 during screening and for the duration of the trial.
Exclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet NONE of the
following criteria:
1. The subject has a history of severe allergic or anaphylactic reactions.
2. The subject has a known allergy or hypersensitivity to any component of the
formulation.
3. The subject has a medical history or current evidence of any clinically significant
(as determined by the investigator) cardiac, endocrine (including diabetes),
hematologic, hepatobiliary (abnormal 12lanine aminotransferase [ALT], aspartate
aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin),
immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or
renal condition, or other major disease.
4. The subject has a history of any malignant disease.
5. The subject has a history of more than one herpes zoster episode or multimetameric
herpes zoster.
6. The subject has a history of an opportunistic infection (e.g. cytomegalovirus,
pneumocystis carinii, aspergillosis, clostridium difficile).
7. The subject has a history of or ongoing chronic or recurrent infectious disease (e.g.
infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
8. The subject has had major trauma or surgery in the 2 months before screening or at any
time between screening and check-in.
9. The subject has had an acute infection within 2 weeks before screening or at any time
between screening and check-in including, but not limited to, history, signs, or
symptoms of a common cold (eg, mild rhinorrhea), untreated oral/dental abnormalities
(e.g. untreated dental caries as determined by examination of the mouth), or untreated
disruption of the skin.
10. The subject has clinically significant abnormal ECG findings at screening, check-in
visits, or predose, as determined by the Investigator.
11. The subject has a supine blood pressure measurement outside the ranges of 90 to 140 mm
Hg systolic or 45 to 90 mm Hg diastolic (measured after a rest of at least 5 minutes)
at screening, check-in, or predose. Note: If either value is out of the range, blood
pressure measurements may be repeated in the supine position at intervals of 5 to 10
minutes up to 3 times. If the mean systolic or diastolic measurement continues to
exceed the stated limits, the subject will be excluded.
12. The subject has a pulse of fewer than 45 beats per minute (bpm) or greater than 100
bpm (measured after a rest of at least 5 minutes) at screening, check-in, or predose.
13. The subject tests positive for tuberculosis (TB) at screening by the QuantiFERON-TB
Gold Test, or has a history of latent, inadequately treated, or active TB.
14. The subject has a known history of, or a positive test result for, hepatitis B surface
antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types
1 or 2 at screening.
15. The subject has used prescription or over-the-counter (OTC) medication (other than =2
g/day paracetamol [acetaminophen] or =800 mg/day ibuprofen), vitamins, or herbal
remedies, within 2 weeks or 5 half-lives before study drug administration, whichever
is longer.
16. The subject has participated in another clinical study of a new investigational drug
or has received an investigational drug within the 3 months or 5 half-lives (if
available) before study drug administration, whichever is longer.
17. The subject has had a loss of more than 400 mL of blood (e.g. a blood donation) within
2 months before study drug administration, or has received any blood, plasma, or
platelet transfusions within 3 months before check-in, or plans to donate blood during
the study or within 3 months after the study.
18. The subject has a history of alcohol abuse (defined as an alcohol intake more than 21
units per week) or a history of drug abuse within the 6 months before study drug
administration, or a history of substance abuse deemed significant by the
investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1
single shot of spirits. The subject will be required to abstain from alcohol
consumption 48 hours prior to screening or check-in.
19. The subject is a current smoker or has a history of smoking.
20. The subject has a positive test for alcohol or drugs of abuse (barbiturates,
methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines,
tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone,
and cotinine) at screening or check-in.
21. The subject is unable to participate in, or successfully complete, the study, in the
opinion of their general practitioner or the investigator, because the subject is any
of the following:
1. mentally or legally incapacitated, or unable to give consent for any reason
2. in custody due to an administrative or a legal decision, or under tutelage, or
being admitted to a sanitarium or social institution
3. unable to be contacted in case of emergency
4. unlikely to cooperate or comply with the clinical study protocol or is unsuitable
for any other reason
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