Status:
COMPLETED
Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection
Lead Sponsor:
Tianjin SinoBiotech Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary ph...
Detailed Description
This experiment was a single-center clinical study with randomized, open, positive drug control and single dose increment. The test group will be conducted in the order of incremental dose from 150μg ...
Eligibility Criteria
Inclusion
- Body mass index (BMI) in the range of 19.0\~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
- Understand and sign the informed consent form
Exclusion
- Persons with allergic physique or sensitive skin;
- Any person with any skin disease;
- have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
- Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
- Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
- Having a fertility plan within 2 weeks of screening and within 6 months of the end of the trial and not having to take it during the trial period
- (a) Effective non-drug contraceptive measures;
- Within 14 days prior to screening or within 5 half-life of the drug (whichever is the oldest of the two) there has been any Prescription drugs, over-the-counter drugs, Chinese herbal medicine, health care products medicine history;
- Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version number: 1.2 Version date: September 30, 2018 26 sexual);
- The percentage of erythrocyte red blood cells ≥ 3%;
- ferritin \<200 ng/ml (male), ferritin \<80 ng/ml (female);
- The use of drugs known to have damage to an organ during the first 3 months of screening;
- A person who has received a blood transfusion or rhEPO treatment;
- Clinically determined to be vitamin B12 or folic acid deficiency;
- Have a history of dizziness and needle sickness;
- A clinical trial person who has participated in other drugs within the first 3 months of screening;
- Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;
- Women during pregnancy and lactation;
- The researchers did not consider it appropriate to enter the trial.
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03786289
Start Date
December 3 2018
End Date
December 9 2019
Last Update
October 8 2020
Active Locations (1)
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1
Beijing you 'an hospital affiliated to capital medical university
Beijing, Beijing Municipality, China, 100069