Lab-Grown blood protein tested in humans for first time
NCT ID NCT05179265
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a lab-made version of human serum albumin, a protein normally found in blood, in 48 healthy adults. The goal was to check safety and how the body processes the drug, not to treat any disease. It is a first step toward possibly using this protein for conditions like fluid buildup in the belly (hepatic ascites) caused by liver disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human serum albumin
- What this could lead to
- If successful, this could lead to a safer or more reliable source of albumin for treating fluid buildup in liver disease patients.
- What could go wrong
- This is a very early Phase 1 trial in only 48 healthy people, so it cannot yet show if the drug works for any disease. Side effects are unknown at this stage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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48 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Jul 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy adults, 18 to 55 years old (including the critical value), male or female; 2. Body weight ≥45 kg, body mass index (BMI) between 18 and 28 kg/㎡ (including the critical value); 3. 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; 4. Be willing to participate in clinical trials and sign Informed Consent Form; 5. Be able to communicate well with researchers and understand and abide by the requirements of this study. Exclusion Criteria: 1. Yeast source antibody positive; 2. 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; 3. 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 ; 4. 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; 5. Previous has a chronic infectious disease and the investigators can judge possible affecting the evaluation of the drug in trial; 6. Surgery of diseases having clinical significance within 4 weeks before administration; 7. Difficulties with blood collection or cannot be resistant to venipuncture , history of needle sickness or blood sickness. 8. Alcohol breath test , smoke test or drug urinary screening is positive; 9. Physical examination, vital signs, 12 lead electrocardiogram, laboratory examination (blood routine, urine routine, blood biochemical examination, etc.) found that there is a clinical significance; 10. One or more positive results for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody; 11. A history of drug abuse, or alcohol abuse ( in other words , drinking more than 14 units of alcohol per week \[1 unit=360 mL beer or 45 mL of 40% alcoholic spirits or 150 mL wine\]) or smoking history (≥5 per day ), or those who cannot smoke during hospitalization; 12. Those who use any caffeine-rich food or beverages (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the study drug, or who do not agree to prohibit the use of caffeine-rich food or beverages during the trial; 13. Those who have special dietary requirements and cannot follow a unified diet; 14. Those who have been treated with corticosteroids or human plasma products within 4 weeks before the trial drug is administered, and have used any prescription drugs, over-the-counter drugs or herbal medicines within 2 weeks (except external preparations or topical preparations); 15. Participated in any drug clinical trial within 3 months before administration; 16. Those who have donated blood within 4 weeks before dosing or plan to donate blood during the study period or within 4 weeks after the end of the study (\>400 mL); 17. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial; 18. Researchers believe that compliance is poor, or those who have other factors that are not suitable for participating in this trial.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
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Shenzhen Protgen Co., Ltd.
Shenzhen, Guangdong, 100084, China
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