| Eligibility |
Inclusion Criteria:
Subjects must meet all the following criteria to be enrolled in the trial
1. Able to understand and willing to sign the ICF
2. Healthy male and female subjects, 18-55 years of age, non-smokers, or subjects must
have been non-smoking for at least 3 months prior to their screening visit.
3. Has adequate venous access
4. With no significant medical history, and in good health as determined by detailed
medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological,
immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease),
full physical examination,vital signs, 12-lead electrocardiogram (ECG), urinalysis and
laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital
signs results may be repeated once if abnormal result is observed at the initial
reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated
measurements.
5. Subjects must have adequate organ function according to the following laboratory
values:
- Bone marrow function (absolute neutrophil count =1500/mm3 and platelet count
=100,000/mm3)
- Adequate liver function [alanine aminotransferase (ALT) to =1.5× upper limit
normal (ULN) and alkaline phosphatase to =1.5× ULN, total bilirubin =1.5 mg/dL]
- Adequate renal function creatinine clearance =60 mL/min based on Cockcroft- Gault
equation, or serum creatinine level =1.5 times the ULN.
6. Be a female of non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is 2 years post-menopausal and have an FSH >
40mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy,
hysterectomy or tubal ligation]) or agree to one of the following to prevent pregnancy
and, if a woman of childbearing potential, have a negative urine pregnancy test at
screening:
- Practicing abstinence
- If a sexually active woman of childbearing potential (sexually active with a
non-sterile male partner) agrees to prevent pregnancy by using double methods of
contraception as follow until at least 30 days after the administration of the
investigational product:
1. simultaneous use of intra-uterine contraceptive device, placed at least 4
weeks prior to study drug administration, and condom for the male partner;
2. simultaneous use of hormonal contraceptives, starting at least 4 weeks prior
to study drug administration and must agree to use the same hormonal
contraceptive throughout the study, and condom for the male partner;
3. simultaneous use of diaphragm with intravaginally applied spermicide and
male condom for the male partner, starting at least 21 days prior to study
drug administration.
- Male subjects who are not vasectomized for at least 6 months and who are sexually
active with a non-sterile female partner must agree to use double methods of
contraception below from the first dose of randomized study drug until 90 days
after their dose and must not donate sperm during their study participation
period:
1. Simultaneous use of a male condom and, for the female partner, hormonal
contraceptives (used since at least 4 weeks) or intra-uterine contraceptive
device (placed since at least 4 weeks);
2. Simultaneous use of a male condom and, for the female partner, a diaphragm
with intravaginally applied spermicide.
7. Body mass index (BMI) 18-30 kg/m2 and body weight = 50.0 kg for males and = 45.0 kg
for females.
8. Blood pressure = 139/89 mm Hg.
9. Subjects are able to follow the study protocol and complete the trial.
10. At least 25% of the enrolled subjects will be of Asian descent, defined as Chinese,
Japanese, Korean, Vietnamese, Hmong, and their offspring.
Exclusion Criteria:
Subjects who meet any of the following criteria cannot be enrolled:
1. History of severe infection within 4 weeks to dosing.
2. Signs and symptoms of any active infection regardless of severity within 2 weeks prior
to dosing.
3. Meals & Dietary Restrictions: No seafood or high-fat food will be served during
confinement in the clinical center
4. Subjects who have any history of allergy to food or drug will be excluded ( Including
allergies, hypersensitivity, or intolerance to rice or rice products )
5. Use of any prescription drugs, herbal supplements, or nonprescription drugs including
oral anti-histamines (for seasonal allergies) within 1 month or 5 half-lives
(whichever is longer) prior to study drug administration, or dietary supplements
within 1 week prior to study drug administration, unless, in the opinion of the
Investigator and Sponsor, the medication will not interfere with the study.
Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen
may be used, but must be documented in the Concomitant medications/Significant
non-drug therapies page of the source data. Any questions of concomitant medications
should be directed to the Sponsor.
6. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the first dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.
7. Donation of blood 12 week prior to dosing.
8. Pregnant, or nursing females.
9. A history of substance abuse, psychiatric and psychological condition that, in the
judgment of the investigator, may interfere with the planned treatment and follow-up,
affect subject compliance or place the subject at high risk from treatment-related
complications
10. A history of severe allergic reaction to any HpHSA component.
11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTcF interval >450 milliseconds [ms])
12. History of or active obstructive disease in biliary tract, liver, kidney and spleen
defined by ultrasound.
13. Subjects who test positive for hepatitis B or C. (no matter carriers or active will be
excluded from the study
14. Subjects who test positive for Syphilis, Human immunodeficiency virus (HIV) positive
will also be excluded from the study.
15. Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to
study drug administration. Seasonal influenza vaccines for injection are generally
killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,
FluMist®) are live attenuated vaccines and are not allowed)
16. Positive Ig E and Ig G against rice at screening
17. History of significant alcohol abuse within one year prior to screening or regular use
of alcohol within six months prior to the screening visit (more than fourteen units of
alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol])
or positive alcohol breath test at screening
18. History of significant drug abuse within one year prior to screening or use of soft
drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs
(such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and
amphetamine derivatives) within 1 year prior to screening
19. Positive urine drug screen, cotinine test, or alcohol breath test at screening
20. Any reason which, in the opinion of the Qualified Investigator, would prevent the
subject from participating in the study.
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