A Study of OsrHSA in Adult Healthy Male and Female Volunteers

NCT04384523 | Completed Phase 1 Results FDA Drug

• 1 other identifier: US-HY1001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ascites Hepatic

Keywords

OsrHSA

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  from date of Informed Consent through Day 30 (Study Completion)

Secondary Outcomes (2)

• Maximum Plasma Concentration [Cmax]

  pre-dose, 0.5 hours after dose initiating, EOI (End of Infusion), and 0.5 hours, 4 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), Day 5, Day 8, Day 15, Day 22, and Day 30 post End of Infusion.

• Number of Participants With ADA Incident Events

  pre-dose, Day 8, Day 15, Day 22, and Day 30 post End of Infusion

Study Arms (5)

OsrHSA 20 mg/kg IV

EXPERIMENTAL

Drug: OsrHSA 20 mg/kg IV; Other: Placebo

OsrHSA 40 mg/kg IV

EXPERIMENTAL

Drug: OsrHSA 40 mg/kg IV; Other: Placebo

OsrHSA 80 mg/kg IV

EXPERIMENTAL

Drug: OsrHSA 80 mg/kg IV; Other: Placebo

OsrHSA 140 mg/kg IV

EXPERIMENTAL

Drug: OsrHSA 140 mg/kg IV; Other: Placebo

OsrHSA 200 mg/kg IV

EXPERIMENTAL

Drug: OsrHSA 200 mg/kg IV; Other: Placebo

Interventions

OsrHSA 20 mg/kg IV DRUG

A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 20 mg/kg IV

OsrHSA 40 mg/kg IV DRUG

A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 40 mg/kg IV

OsrHSA 80 mg/kg IV DRUG

A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 80 mg/kg IV

OsrHSA 140 mg/kg IV DRUG

A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 140 mg/kg IV

OsrHSA 200 mg/kg IV DRUG

A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 200 mg/kg IV

Placebo OTHER

Normal Saline (0.9% Sodium Chloride)

OsrHSA 140 mg/kg IV; OsrHSA 20 mg/kg IV; OsrHSA 200 mg/kg IV; OsrHSA 40 mg/kg IV; OsrHSA 80 mg/kg IV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all the following criteria to be enrolled in the trial
• Able to understand and willing to sign the ICF
• 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.
• Has adequate venous access
• 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.
• 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.
• 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:
• simultaneous use of intra-uterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
• 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;
• 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.

You may not qualify if:

• Subjects who meet any of the following criteria cannot be enrolled:
• History of severe infection within 4 weeks to dosing.
• Signs and symptoms of any active infection regardless of severity within 2 weeks prior to dosing.
• Meals \& Dietary Restrictions: No seafood or high-fat food will be served during confinement in the clinical center
• Subjects who have any history of allergy to food or drug will be excluded ( Including allergies, hypersensitivity, or intolerance to rice or rice products )
• 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.
• 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 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
• A history of severe allergic reaction to any HpHSA component.
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval \>450 milliseconds \[ms\])
• History of or active obstructive disease in biliary tract, liver, kidney and spleen defined by ultrasound.
• Subjects who test positive for hepatitis B or C. (no matter carriers or active will be excluded from the study
• Subjects who test positive for Syphilis, Human immunodeficiency virus (HIV) positive will also be excluded from the study.

Sponsors & Collaborators

• Healthgen Biotechnology Corp.: lead

Study Sites (1)

WCCT Global, Inc

Cypress, California, 90630, United States

Location

Results Point of Contact

• Title: Daichang Yang
• Organization: Wuhan Healthgen Biotechnology Corp.

dyang@oryzogen.com

18602708398

Study Officials

• David Nguyen, MD, MBA

  WCCT Global, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: May 12, 2020
• Study Start: November 4, 2019
• Primary Completion: March 17, 2020
• Study Completion: July 13, 2020
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)