Recombinant Human Serum Albumin in Healthy Subjects (NCT05179265) | Clinical Trial Compass
CompletedPhase 1
Recombinant Human Serum Albumin in Healthy Subjects
China48 participantsStarted 2021-03-29
Plain-language summary
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics.
Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation, and 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy adults, 18 to 55 years old (including the critical value), male or female;
✓. Body weight ≥45 kg, body mass index (BMI) between 18 and 28 kg/㎡ (including the critical value);
✓. Throughout the study period (from screening to 3 months after the end of the study), subjects or their spouses voluntarily use effective contraceptive methods, such as abstinence, condoms, intrauterine device (IUD), and double barrier method (such as condoms and diaphragm), and there was no sperm donation plan for men;
✓. Be willing to participate in clinical trials and sign Informed Consent Form;
✓. Be able to communicate well with researchers and understand and abide by the requirements of this study.
Exclusion criteria
✕. Yeast source antibody positive;
✕. Investigators consider that there is a clinically significant drug or food allergy, allergic disease history or allergic constitution (≥2 substance allergies), or explicitly allergic to this product or its similar albumin preparation ingredient;
✕. History of clinical serious disease, including but not limited to circulatory systems, endocrine systems, gastrointestinal tract, kidneys, nervous systems, blood systems, immune systems, mental disease and metabolic abnormalities, and investigators consider that not suitable for clinical trials ;
✕. History of cardiovascular system disease, including but not limited to vital signs abnormalities (such as systolic pressure \<90 mmHg or\> 140 mmHg, diastolic pressure \<50 mmHg or\> 90 mmHg, heart rate \<50 bpm or\> 100 bpm), severe arrhythmia, Heart failure, unstable angina pectoris, myocardial infarction occurred six months prior to screening ､the tachycardia / translucent that needs drug therapy, three-degree atrioventricular block, QTC interval≥450 ms or electrocardiogram has a clinically significant abnormality;