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

Phase 1

Completed

• Conditions: Ascites
• Interventions: Drug: Placebo; Drug: human albumin injection; Drug: recombinant human albumin injection

• Registration Number: NCT04641364
• Lead Sponsor: The First Hospital of Jilin University

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.

Study Timeline

• Study Start: 2019-06-24
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2020-09
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Study First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

1. Cigarettes Smoking subjects.
2. Allergic constitution (multiple drugs and food allergies);
3. History of drug use and/or alcohol abuse;
4. Blood donation or massive blood loss (> 450 mL) within three months before screening;
5. Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine within 14 days before screening;
6. Diet or exercise have changed recently;
7. Using study drugs within three months;
8. Risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
9. ECG abnormalities (QTc > 470ms for males, > 480ms for females);
10. Female subjects are in lactation. Pregnancy test is positive;
11. Other Clinical laboratory tests abnormalities;
12. Viral screening test is positive, including HBV, HCV, HIV, and Treponema pallidum;
13. Developing Acute disease;
14. Eating chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours prior to the use of the study drug;
15. Taking any alcoholic products. Alcohol test is positive..
16. Drug test is positive. History of drug abuse or drug use in the past five years;
17. Inability for intravenous injection or blood collection;
18. 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.
19. Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the simplified MDRD formula);
20. History of glaucoma, eye disease.
21. History of cancer or other serious systemic diseases, especially heart, liver, kidney, digestive tract, nervous system, metabolic abnormalities, immune abnormalities or mental disorders;
22. History of immunodeficiency or hypofunction;
23. Received major surgery within 2 years.
24. Other subjects by investigator opinion..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: placebo	Placebo	Subjects received 0.9% sodium chloride injection.
Control: Human Serum Albumin(HSA)	human albumin injection	Subjects received Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles.
Experimental:recombinant human albumin	recombinant human albumin injection	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.

Primary Outcome Measures

Name	Time	Method
Safety and tolerance	Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.	AE

Secondary Outcome Measures

Name	Time	Method
PK parameters	Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.	half life (t1/2）
Pharmacodynamic parameters	Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.	Plasma colloid osmotic pressure
Immunogenicity	Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.	Percentage of patients with positive reaction

Trial Locations

Locations (1)

the first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China