| Eligibility |
Key Inclusion Criteria:
1. Healthy males or females, 18-55 year old, inclusive, with body mass index (BMI)
between 18 and 30 kg/m2, inclusive, and body weight not less than 50 kg.
2. In good general health, free from clinically significant medical or psychiatric
illness or disease (as determined by medical/surgical history, physical examination,
weight, 12-lead ECG, and clinical laboratory tests).
3. with normal cardiac conduction and function at screening
4. Nonsmoker within the previous 6 months (before screening), and does not use tobacco
containing, or nicotine-containing products
5. Has normal clinical chemistry, hematology, coagulation, and complete urinalysis
(fasted for at least 8 hours) results at screening and Day -1
6. Has a negative urine drug screen result at screening and on Day -1.
7. For all female participants, have a negative urine pregnancy test at screening and on
Day -1, and must not be breastfeeding. Female participants of childbearing potential
must agree to use a protocol-approved method of non-hormonal contraception as detailed
in Appendix 4 from signing of the informed consent, throughout the duration of the
study and for 30 days after the last dose of study drug.
8. Male participants who are nonsterilized and sexually active with a female partner of
childbearing potential must agree to use a protocol-approved method of non-hormonal
contraception as detailed in Appendix 4 from signing of the informed consent,
throughout the duration of the study and for 30 days after the last dose of study
drug.
9. Male participants must agree to not donate sperm during the study and for 3 months (90
days) after receiving the last dose of study drug.
Key Exclusion Criteria:
1. Has a history of or current clinically significant medical illness including (but not
limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities,
gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic
disease, metabolic disturbances, or any other current physical condition that the
investigator considers should exclude the participant, or that could interfere with
the interpretation of the study results.
2. Has current or recent (within 6 months) history of gastrointestinal disease (except
for appendectomy, inguinal/umbilical hernia), or any surgical or medical condition
such as Crohn's disease or liver disease, that could potentially alter the absorption,
metabolism, or excretion of the study drugs.
3. Has any clinically significant medical condition, physical examination finding, ECG
abnormality, or clinically significant abnormal value for clinical chemistry,
hematology, coagulation, or urinalysis at Screening or at admission to the study
center, as deemed appropriate by the investigator.
4. Has any of the following (participant may rescreen once for failure to meet criteria
at Screening):
- SBP >150 mmHg at Screening stable (measured in supine position)
- DBP of >95 mmHg at Screening stable (measured in supine position).
5. History or presence of malignancy within the past 5 years, except for adequately
treated localized skin cancer (basal cell or squamous cell carcinoma), which is
allowed.
6. Currently suffers from clinically significant systemic allergic disease, or has a
history of significant drug allergies, including but not limited to:
- A history of anaphylactic reaction
- Allergic reaction due to any drug that led to significant morbidity
7. Known hypersensitivity to any component of the formulation of HA115.
8. Has donated blood or had an acute loss of blood (>500 mL) during the 3 months before
study drug administration or intends to donate blood or blood products within 3 months
after the completion of the study.
9. Has had an acute, clinically significant illness within 30 days prior to Day 1, or has
had a recent febrile illness with an abnormal body temperature for at least 72 hours
before dosing on Day 1.
10. Has a history (within the past 12 months before Screening) of drug abuse (defined as
any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption
exceeding 14 units per week), or a positive test for drugs of abuse at Screening or
upon admittance to the testing facility (Day -1) or is unwilling to abstain from
alcohol and drugs of abuse throughout the study.
11. Has a smoking history during the past 6 months before Screening. This includes the use
of any nicotine containing substances (e.g., nicotine patch or gum, chewing tobacco, e
cigarettes), or has a positive cotinine test at Screening or Day -1, or is unwilling
to abstain from these products for the duration of the study.
12. Has ever received HA115 in a previous clinical study or has used any investigational
compound and/or an experimental medical device within 3 months before study drug
administration.
13. If male, the participant intends to impregnate others, or donate sperm during this
study or for 3 months after receiving the last dose of study drug.
14. Has inadequate venous access for the required blood draws for the study.
15. Is unable to meet or perform study requirements or has a known or suspected inability
to comply with the study protocol.
16. Is unable or unwilling to eat provided food (e.g., vegetarian, kosher, lactose
intolerant dietary requirements).
17. Is an immediate family member of the investigator, or an employee of the study center
with direct involvement in the proposed study or other studies under the direction of
the investigator or study center or is in a dependent relationship with a study site
employee who is involved in the conduct of this study (eg, spouse, parent, child,
sibling), or may consent under duress.
18. Has been on a significantly abnormal diet during the 4 weeks preceding the first dose
of study medication.
19. Has participated in another clinical trial within 60 days prior to the first dose of
study medication.
20. Use of any over-the-counter (OTC) medication (including nutritional or dietary
supplements, herbal preparations, or vitamins) within 7 days prior to the first dose
of study medication until the end of study visit without evaluation and approval by
the investigator.
21. Use of any prescription medication from 14 days prior to the first dose of study
medication until the end-of-study visit.
22. Has been treated with any known drugs that are moderate or strong inhibitors/inducers
of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine,
carbamazepine) within 30 days prior to the first dose of study medication, and that,
in the investigator's judgment, may impact participant safety or the validity of the
study results.
23. Engagement in strenuous exercise from 48 hours prior to the first dose of study
medication until the end-of-study visit.
24. Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds,
broccoli, Brussel sprouts, pomegranate, star fruit, char-grilled meat, or
caffeine/xanthine from 48 hours prior to the first dose of study medication until the
end of study visit. P25. Is a female participant with a positive pregnancy test
result.
25. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human
immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis
B, hepatitis C, or HIV infection.
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