New rabies shot could shield millions after bites
NCT ID NCT07445815
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a lab-made antibody injection designed to prevent rabies after exposure. About 200 healthy adults aged 18-60 will receive the injection to check its safety and how well it boosts rabies-fighting antibodies. The goal is to find a reliable treatment that can be used after a potential rabies exposure.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- 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 60 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 individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification. 2. Participants voluntarily agree to participate in the study and sign an informed consent form. 3. Female participants must have no plans for pregnancy or egg donation from 14 days prior to dosing until 6 months after dosing and must voluntarily adopt effective physical contraceptive measures. Male participants must have no plans for pregnancy or sperm donation within 6 months after dosing and must voluntarily adopt effective physical contraceptive measures. 4. Female participants must weigh ≥45.0 kg and ≤80.0 kg, and male participants must weigh ≥50.0 kg and ≤80.0 kg. Body mass index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight in kg / height in m²). 5. Vital signs (reference ranges: systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-100 beats per minute, all inclusive; body temperature assessed by the investigator according to the research center's standards), physical examination, and clinical laboratory and auxiliary tests during the screening period must be normal or judged by the investigator to have no clinical significance if abnormal. Exclusion Criteria: 1. Known allergy to the investigational product (including excipients or similar drugs), or individuals with a history of severe allergic diseases or considered allergic constitution (e.g., allergies to two or more drugs, foods, or pollen) as judged by the investigator to potentially compromise participant safety. 2. Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants). 3. History of clinically severe diseases within the 6 months (180 days) prior to screening that remain unresolved, or current acute or chronic illnesses that may significantly affect the metabolism or safety evaluation of the investigational product. 4. History of autoimmune diseases or chronic hepatitis. 5. History of seizures, epilepsy, psychiatric or neurological disorders, or family history of seizures or epilepsy. 6. Major surgery within the 3 months (90 days) prior to screening, or surgery that may significantly affect the metabolism or safety evaluation of the investigational product. 7. Previous vaccination with human rabies vaccine, or suspected history of rabies exposure (defined as bites, scratches, licks on mucous membranes or broken skin by rabid, suspected rabid, or undetermined rabies status animals, or direct contact of open wounds or mucous membranes with saliva or tissues potentially containing rabies virus), as determined by inquiry. 8. Positive screening for anti-rabies virus antibodies during the screening period. 9. Vaccination with any vaccine other than the rabies vaccine within the 1 month (30 days) prior to screening. 10. Use of other antibody-based drugs or immunoglobulins within the 3 months (90 days) prior to screening. 11. Use of passive immunizing agents, immunosuppressants, or corticosteroids within the 3 months (90 days) prior to screening. 12. Use of medications that may affect the metabolism or safety evaluation of the investigational product within the 14 days prior to screening or ongoing use of such medications. 13. Participation in any clinical trial involving the use of investigational drugs or devices within the 3 months (90 days) prior to screening, or planned participation in other clinical trials during this study. 14. Regular alcohol consumption within the 3 months (90 days) prior to screening, averaging more than 2 alcohol units per day (1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% spirits, or 147 mL of 12% wine), or inability to abstain from alcohol during the trial period. 15. Smoking habit within the 3 months (90 days) prior to screening (more than 5 cigarettes or equivalent tobacco per day), or inability to abstain from smoking during the trial period. 16. Blood loss/donation exceeding 300 mL (excluding physiological blood loss in females) within the 3 months (90 days) prior to screening, receipt of blood transfusions or blood products, or plans to donate blood within 1 month (30 days) after the trial. 17. Inability to avoid strenuous exercise within 14 days after dosing. 18. History of drug abuse. 19. Pregnant or breastfeeding women. 20. History of needle or blood phobia, poor vascular condition, or intolerance to venipuncture. 21. Participants who may be unable to cooperate in completing the study for other reasons or are deemed unsuitable for inclusion by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lanzhou Institute of Biological Products Co., Ltd.
Lanzhou, Gansu, 730000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Rabies vaccine batch check: will it pass the test?
- New rabies vaccine schedule tested in 2,000 volunteers
- New rabies vaccine shows promise in preventing deadly infection
- Promising new rabies vaccine passes phase 3 test
- New rabies vaccine shows promise in large thai trial