Clinical trial: Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects. (NCT04641364)

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:

          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..
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment