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

Healthgen Biotechnology Corp.1 site in 1 country48 target enrollmentMarch 22, 2022

ConditionsEmphysema Secondary to Congenital AATD

InterventionsOsrhAAT 3 mg/kg IV OsrhAAT 1 mg/kg IV OsrhAAT 10 mg/kg IV OsrhAAT 20 mg/kg IV OsrhAAT 40 mg/kg IV OsrhAAT 60 mg/kg IV

DrugsOsrhAAT 1 mg/kg IV OsrhAAT 3 mg/kg IV OsrhAAT 10 mg/kg IV OsrhAAT 20 mg/kg IV OsrhAAT 40 mg/kg IV OsrhAAT 60 mg/kg IV

Overview

Phase: Phase 1
Intervention: OsrhAAT 3 mg/kg IV
Conditions: Emphysema Secondary to Congenital AATD
Sponsor: Healthgen Biotechnology Corp.
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and tolerability: Incidence of adverse events (AEs), serious adverse events (SAEs), and infusion site reactions
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 22, 2022

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Healthgen Biotechnology Corp.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all the following criteria to be enrolled in the trial:
•Able to understand and willing to sign the ICF
•Healthy subjects, male or female, non-smokers, 18-55 years of age
•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.
•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.
•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:

Exclusion Criteria

•Subjects who meet any of the following criteria cannot be enrolled:
•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.
•History of hypersensitivity to OsrhAAT or any excipient or similar drugs
•Known History of hypersensitivity to rice
•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.
•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.
•Donation of blood 12 week prior to dosing
•Pregnant, or nursing females
•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
•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）

Arms & Interventions

OsrhAAT 3 mg/kg IV

Intervention: OsrhAAT 3 mg/kg IV

OsrhAAT 1 mg/kg IV

Intervention: OsrhAAT 1 mg/kg IV

OsrhAAT 10 mg/kg IV

Intervention: OsrhAAT 10 mg/kg IV

OsrhAAT 20 mg/kg IV

Intervention: OsrhAAT 20 mg/kg IV

OsrhAAT 40 mg/kg IV

Intervention: OsrhAAT 40 mg/kg IV

OsrhAAT 60 mg/kg IV

Intervention: OsrhAAT 60 mg/kg IV

Outcomes

Primary Outcomes

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

Time Frame: Adverse events (AE) will be collected from the time of informed consent until EOS. SAE will be collected by the Investigator from the informed consent through 180 days.