Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.

NCT04641364 | Completed Phase 1 DMC

• 1 other identifier: ART-2019-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects

Conditions

Ascites

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance

  AE

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

Secondary Outcomes (6)

• PK parameters

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

• PK parameters

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

• PK parameters

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

• Pharmacodynamic parameters

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

• Pharmacodynamic parameters

  Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.

Study Arms (3)

Control: placebo

PLACEBO COMPARATOR

Subjects received 0.9% sodium chloride injection.

Drug: Placebo

Control: Human Serum Albumin(HSA)

ACTIVE COMPARATOR

Subjects received Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles.

Drug: human albumin injection

Experimental:recombinant human albumin

EXPERIMENTAL

Subjects received recombinant Human Serum Albumin, 1.25g, 5g, 10g, 20g, 30 g for the single dose study. For the multiple dose study, subjects received recombinant Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles.

Drug: recombinant human albumin injection

Interventions

recombinant human albumin injection DRUG

single dose or multiple doses of intravenous infusion

Also known as: Intravenous infusion of recombinant human albumin injection

Experimental:recombinant human albumin

Placebo DRUG

Single dose intravenous infusion of 0.9% sodium chloride injection

Also known as: Intravenous infusion of 0.9% sodium chloride injection

Control: placebo

human albumin injection DRUG

multiple doses of intravenous infusion

Also known as: Intravenous infusion of human albumin injection

Control: Human Serum Albumin(HSA)

Eligibility Criteria

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

You may qualify if:

• ）Informed consent form signed; 2) To be able to complete the study; 3) Subjects (including partners) are willing to take contraceptive measures; 4) 18-55 years of age; 5) Male subjects are no less than 50 kg.Female subjects are no less than 45 kg. Body mass index is 18-28kg / m2; 6) Normal cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 50%; 7) Physical examination and vital signs are normal.

You may not qualify if:

• Cigarettes Smoking subjects.
• Allergic constitution (multiple drugs and food allergies);
• History of drug use and/or alcohol abuse;
• Blood donation or massive blood loss (\> 450 mL) within three months before screening;
• Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine within 14 days before screening;
• Diet or exercise have changed recently;
• Using study drugs within three months;
• Risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
• ECG abnormalities (QTc \> 470ms for males, \> 480ms for females);
• Female subjects are in lactation. Pregnancy test is positive;
• Other Clinical laboratory tests abnormalities;
• Viral screening test is positive, including HBV, HCV, HIV, and Treponema pallidum;
• Developing Acute disease;
• Eating chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours prior to the use of the study drug;
• Taking any alcoholic products. Alcohol test is positive..

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Ascites

Interventions

Sodium Chloride; Serum Albumin, Human

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Junqi Niu, Dr

  The first affiliated hospital of Jilin University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 23, 2020
• Study Start: June 24, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)