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

• Status: Completed
• Trial end date: 2020-05-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: First Hospital of Jilin University; The First Hospital of Jilin University

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:

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..