A Study of OsrHSA in Adult Healthy Male and Female Volunteers
Condition: Ascites Hepatic
MeSH terms: Ascites
Intervention: OsrHSA 20 mg/kg IV; OsrHSA 40 mg/kg IV; OsrHSA 80 mg/kg IV; OsrHSA 140 mg/kg IV; OsrHSA 200 mg/kg IV; Placebo
Intervention description: A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min; A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min; Normal Saline (0.9% Sodium Chloride)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study in healthy volunteers to evaluate safety, tolerability, PK, PD and immunogenicity of OsrHSA.
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: OsrHSA

Summary:

      A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of
      OsrHSA in adult healthy male and female volunteers
    

Eligibility criteria:

        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.