| Eligibility |
Inclusion Criteria:
- Subjects who meet all the following criteria at screening may be included in the
study:
1. Ethnically Chinese men or women, 18 to 45 years of age (inclusive).
2. Body weight: male =50 kg, female =45 kg; body mass index (BMI) within 18 to 26
kg/m2 (inclusive).
3. Healthy subject as determined by medical evaluation including medical history,
physical examination, clinical laboratory tests, vital signs.
4. Able to comprehend and willing to sign the ICF which includes compliance with the
inclusion and exclusion criteria listed in the ICF and in the protocol.
5. Non-smoker or ex-smoker for >6 months.
6. From the time they sign the informed consent to 90 days (male subject within 30
days) after dosing, subjects have no plans to have children and voluntarily use
effective contraception
Exclusion Criteria:
- Any of the following will exclude subjects from the study:
1. Have a history of, or current clinically significant medical illness including
but not limited to, cardiac arrhythmias or other cardiac disease; hematologic
disease; coagulation disorders (including any abnormal bleeding or blood
dyscrasias); significant pulmonary disease, including bronchospastic respiratory
disease; diabetes mellitus; hepatic or renal disease; thyroid disease; neurologic
or psychiatric disease; or any other illness that the investigator considers
should exclude the subject or that could interfere with the interpretation of the
study results.
2. A history of atrioventricular (AV) block, (1st, 2nd or 3rd degree), myocardial
infarction (MI) or angina, non-sustained or sustained ventricular tachycardia
(VT), torsade de pointes, family history of sudden death or prolonged QT
interval, vaso-vagal syncope, sick sinus syndrome, supraventricular tachycardia,
atrial flutter, atrial fibrillation (AFib), stroke, transient ischemic attack
(TIA), unexplained syncope, congestive heart failure (CHF).
3. Acute upper respiratory tract infection within 14 days prior to dosing.
4. Any abnormality of the nasal passage.
5. Unable to tolerate IN administration.
6. Known sensitivity to verapamil or other drugs or foods.
7. Clinically significant abnormal values for clinical laboratory tests at screening
as deemed appropriate by the investigator.
8. Serum potassium <3.5mmol/L or serum magnesium <0.75mmol/L or serum calcium
<2.11mmol/L.
9. Systolic blood pressure (SBP) <100 or >140 mmHg, diastolic blood pressure (DBP)
<55 or >90 mmHg, HR <65 or >95 bpm.
10. QTcF >440 msec, flat or biphasic T waves, QRS >105 ms, evidence of a prior MI,
pathologic U waves or U waves that interfere with the QT measurement, AV block or
left anterior hemiblock (LAHB) or left posterior hemiblock (LPHB) or right bundle
branch block (RBBB) or left bundle branch block (LBBB), pre-excitation syndrome.
11. Clinically significant abnormal physical examination, vital signs or 12-lead ECG
at screening as deemed appropriate by the Investigator.
12. Have a history of human immunodeficiency virus (HIV) antibody positive, or tests
positive for HIV; have a history of treponema pallidum antibody positive, or
tests positive for treponema pallidum; have a history of hepatitis B virus
surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) positive, or other
clinically active liver disease, or tested positive for HBsAg or HCVAb at
screening.
13. History of drug or alcohol abuse in the last 2 years..
14. Positive test result(s) for alcohol and/or drugs of abuse at screening or
admission (Day-1).
15. Received an investigational drug or used an invasive investigational medical
device within 1 month or within a period less than 10 times the drug's half-life,
whichever is longer, before dosing.
16. Use of any prescription or non-prescription medication within 14 days or 5
half-lives (whichever is longer), or complementary and alternative medicine
within 28 days before dosing (excluding aspirin, ibuprofen, and acetaminophen).
17. Any blood donation within 60 days prior to dosing, or any plasma donation within
30 days prior to dosing, or receipt of blood products within 60 days prior to
dosing.
18. Vaccinated within 30 days prior to dosing or planned to be vaccinated during this
study.
19. Have preplanned surgery or procedures that will interfere with the conduct of the
study.
20. Sponsor staff and/or staff at the study site.
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