A Phase I of OsrhAAT in Healthy Volunteers

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Brief Title

Study of OsrhAAT or Placebo in Healthy Volunteers

Official Title

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in Healthy Volunteers

Brief Summary

      A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety,
      Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in
      Healthy Volunteers
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and infusion site reactions


Condition

AATD

Intervention

OsrhAAT 1 mg/kg IV

Study Arms / Comparison Groups

 OsrhAAT 1 mg/kg IV
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

March 22, 2022

Completion Date

June 30, 2023

Primary Completion Date

March 31, 2023

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 subjects, male or female, non-smokers, 18-55 years of age

          3. 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.

          4. Adequate organ function according to the following laboratory values:

               -  Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count
                  ≥100,000/mm3).

               -  Alanine aminotransferase (ALT) 7-56 units per liter of serum ( or institutional
                  equivalent), AST 5-40 units per liter of serum (or institutional equivalent),
                  alkaline phosphatase 20-140 units per liter of serum (or institutional
                  equivalent), total bilirubin 0.1-1.0 mg/dL (or institutional equivalent) and
                  creatinine clearance (Cockcroft-Gault equation) ≥90mL/min.

          5. Female of non-childbearing potential (i.e., physiologically incapable of becoming
             pregnant, including any female who is 1 year of post-menopausal with a 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 pregnancy test at screening:

               -  Practicing abstinence which is the preferred and usual lifestyle of the subject

               -  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 180 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 120 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

          6. Body mass index (BMI) 18.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and

               -  45.0 kg for females

          7. Blood pressure ≤ 139/89 mm Hg

          8. Able to follow the study protocol and complete the trial

        Exclusion Criteria:

        Subjects who meet any of the following criteria cannot be enrolled:

          1. History of severe infection within 4 weeks prior to administration; signs and symptoms
             of any active infection regardless of severity within 2 weeks prior to administration.

          2. History of hypersensitivity to OsrhAAT or any excipient or similar drugs

          3. Known History of hypersensitivity to rice

          4. Use of any prescription drugs, herbal supplements, or nonprescription drugs, including
             oral antihistamines (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 the 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.

          5. 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.

          6. Donation of blood 12 week prior to dosing

          7. Pregnant, or nursing females

          8. A history of 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

          9. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 milliseconds [ms], Bazett Formula: QTc=QT/RR0.5)

         10. Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000
             cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled, in
             the judgement of the Investigator.

         11. Known infection with human immunodeficiency virus (HIV) and a cluster of
             differentiation 4 (CD4) count that is unknown or documented to be < 350 cells/mm3
             within 12 months, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness

         12. Known history of severe IgA deficiency

         13. 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

         14. Receipt of an immunoglobulin or blood product 90 days prior to dosing

         15. History of consuming more than 14 units of alcoholic beverages per week or of
             alcoholism or drug/chemical/substance abuse within past 2 years prior to screening
             (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). Consumed
             > 3 (male) or 2 (female) units of alcohol as determined by blood alcohol testing at
             screening

         16. History of significant drug abuse within one year prior to screening

         17. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids,
             cocaine, cotinine and opiates)

         18. Any reason which, in the opinion of the Investigator, would prevent the subject from
             participating in the study
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 714-252-0700, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05315921

Organization ID

HY1003-2021-P1


Responsible Party

Sponsor

Study Sponsor

Healthgen Biotechnology Corp.


Study Sponsor

, , 


Verification Date

April 2022