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

Primary Purpose

Ascites

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

recombinant human albumin injection

Placebo

human albumin injection

About this trial

This is an interventional treatment trial for Ascites

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1）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.

Exclusion Criteria:

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..
Drug test is positive. History of drug abuse or drug use in the past five years;
Inability for intravenous injection or blood collection;
Using biological products (including live vaccines) within the last 3 months. Planing to use vaccines during the study period. Having received corticosteroid or human plasma product system treatment within 1 month.
Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the simplified MDRD formula);
History of glaucoma, eye disease.
History of cancer or other serious systemic diseases, especially heart, liver, kidney, digestive tract, nervous system, metabolic abnormalities, immune abnormalities or mental disorders;
History of immunodeficiency or hypofunction;
Received major surgery within 2 years.
Other subjects by investigator opinion..

Sites / Locations

the first hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Control: placebo

Control: Human Serum Albumin(HSA)

Experimental:recombinant human albumin

Arm Description

Subjects received 0.9% sodium chloride injection.

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

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.

Outcomes

Primary Outcome Measures

Safety and tolerance

Secondary Outcome Measures

PK parameters

Maximum Plasma Concentration（Cmax）

PK parameters

time to Maximum Plasma Concentration（Tmax）

PK parameters

half life (t1/2）

Pharmacodynamic parameters

Red blood cell specific volume

Pharmacodynamic parameters

Plasma colloid osmotic pressure

Immunogenicity

Percentage of patients with positive reaction

Full Information

NCT ID

NCT04641364

First Posted

October 12, 2020

Last Updated

November 20, 2020

Sponsor

The First Hospital of Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT04641364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 24, 2019 (Actual)

Primary Completion Date

May 6, 2020 (Actual)

Study Completion Date

May 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy volunteers. The safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in a single center, randomized, double-blind, placebo-controlled single dose incremental trial in healthy volunteers. The study was divided into two stages: the first stage was a single dose and dose increasing stage (including 5 dose groups with increasing dose, and each group was set with placebo control); the second stage was multiple administration stage (with positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early clinical data of recombinant human albumin were collected and analyzed in the two stages. The initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5, 10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The dosage was 10 g / Day in multiple administration stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ascites

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control: placebo

Arm Type

Placebo Comparator

Arm Description

Subjects received 0.9% sodium chloride injection.

Arm Title

Control: Human Serum Albumin(HSA)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Experimental:recombinant human albumin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

recombinant human albumin injection

Other Intervention Name(s)

Intravenous infusion of recombinant human albumin injection

Intervention Description

single dose or multiple doses of intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Intravenous infusion of 0.9% sodium chloride injection

Intervention Description

Single dose intravenous infusion of 0.9% sodium chloride injection

Intervention Type

Drug

Intervention Name(s)

human albumin injection

Other Intervention Name(s)

Intravenous infusion of human albumin injection

Intervention Description

multiple doses of intravenous infusion

Primary Outcome Measure Information:

Title

Safety and tolerance

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

PK parameters

Description

Maximum Plasma Concentration（Cmax）

Time Frame

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

Title

PK parameters

Description

time to Maximum Plasma Concentration（Tmax）

Time Frame

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

Title

PK parameters

Description

half life (t1/2）

Time Frame

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

Title

Pharmacodynamic parameters

Description

Red blood cell specific volume

Time Frame

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

Title

Pharmacodynamic parameters

Description

Plasma colloid osmotic pressure

Time Frame

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

Title

Immunogenicity

Description

Percentage of patients with positive reaction

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1）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. Exclusion Criteria: 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.. Drug test is positive. History of drug abuse or drug use in the past five years; Inability for intravenous injection or blood collection; Using biological products (including live vaccines) within the last 3 months. Planing to use vaccines during the study period. Having received corticosteroid or human plasma product system treatment within 1 month. Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the simplified MDRD formula); History of glaucoma, eye disease. History of cancer or other serious systemic diseases, especially heart, liver, kidney, digestive tract, nervous system, metabolic abnormalities, immune abnormalities or mental disorders; History of immunodeficiency or hypofunction; Received major surgery within 2 years. Other subjects by investigator opinion..

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junqi Niu, Dr

Organizational Affiliation

The first affiliated hospital of Jilin University

Official's Role

Study Director

Facility Information:

Facility Name

the first hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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