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Not yet recruitingNCT06548139Updated Aug 12, 2024

Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials

A Phase 2 interventional study of Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg and Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg in Rabies Virus Infection, sponsored by Changchun BCHT Biotechnology Co.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Changchun BCHT Biotechnology Co. · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people

Read the detailed description

To evaluate the rabies virus neutralizing antibody (RVNA) activity of rabies mAb CBB 1 in combination with human rabies vaccine (Vero cells) in healthy volunteers.

To evaluate the safety and tolerability of rabies mAb CBB 1 compared to HRIG in combination with human rabies vaccine (Vero cells) in healthy volunteers.

To evaluate the immunogenicity of rabies mAb CBB 1.

02

Conditions studied

  • Rabies Virus Infection

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Keywords

  • Rabies Virus Neutralizing Antibodies
  • Safety
  • Immunogenicity
03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's planned enrollment of 120 is below the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Changchun BCHT Biotechnology Co. is the lead sponsor of 22 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written ;
  2. Men or women aged 18\~50 (including boundary values) at the time of screening;
  3. The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
  4. Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical , while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.

Exclusion criteria

Exclusion Criteria:

  1. Those who are known to be allergic to the study drug (including , similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);
  2. Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
  3. Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);
  4. Patients with a previous history of diseases or chronic hepatitis (inquiry);
  5. Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
  6. Those who have received major surgery within 3 months (90 days) prior to the first dose, or those who may significantly affect the internal process or safety evaluation of the study drug (inquiry, inquiry);
  7. Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);
  8. Suspected or clear identification of a history of injuries to warm-blooded mammals in the last 12 months (360 days) (warm-blooded animals refer to animals that can regulate their body temperature, also known as endotherms. Birds and the vast majority of mammals, including the cats and dogs around them, are warm-blooded animals) (inquiry);
  9. Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);
  10. Those who have used a rabies passive immunization preparation or used systemic agents such as within 3 months (90 days) prior to the first dose (inquiry, inquiry);
  11. Those who have been used or are in the current period) or who may have a significant impact on the in vivo process or safety evaluation of the study drug (inquiry, inquiry);
  12. Any clinical trial drug or device used within 3 months (90 days) prior to the first dose, or \<5 half-lives of the last previous trial drug dose (whichever is older), or planned to participate in other clinical trials during the study (inquiry, inquiry);
  13. Regular alcohol for 3 months (90 days) before the first dose (3 times a week, and an average of 50° of liquor 200 ml) (inquiry);
  14. Those with positive alcohol breath test or test value> 0 mg / 100 ml (examination);
  15. Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);
  16. Those who lost blood / donated more than 400 ml (other than female physiological blood loss) within 3 months (90 days) before the first dose, or who received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month (30 days) after the end of the trial (inquiry);
  17. Those who ingested alcohol-containing products within 24 hours before the first dose (inquiry);
  18. Abnormalities at the administration site (such as inflammation, induration, redness, large area scar or tattoo, etc.) shall affect the administration or the clinical observer (examination);
  19. Those with a history of substance abuse (inquiry);
  20. Those who are screened positive for substance abuse during the screening period (examination);
  21. Those who are positive for the initial screening during the screening period (screening);
  22. two half and half qualitative tests of during the screening period (examination);
  23. Patients with positive results for virus antibody or treponema pallidum antibody during the screening period (examination);
  24. Physical examination, vital signs (respiration, blood pressure, pulse rate), , other laboratory tests (laboratory tests not listed separately) or other auxiliary examination results are judged as abnormal and by the study doctor (examination);
  25. Ear temperature during the screening period is> 37.5℃ (examination);
  26. Women who are positive in pregnancy or lactation or screening pregnancy test (inquiry, examination);
  27. Patients with a history of needle acupuncture, blood sickness, or unable to tolerate venipuncture (inquiry);
  28. The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Experimental group 1

    Natural full human monoclonal antibody CBB 1 injection:Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart.

    Drug: Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg · Biological: Lyophilized rabies vaccine for human use (Vero cells)

  • Experimental
    Experimental group 2

    Natural full human monoclonal antibody CBB 1 injection:Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart.

    Drug: Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg · Biological: Lyophilized rabies vaccine for human use (Vero cells)

  • Active comparator
    Positive control group

    Rabies Human Immunoglobulin (HRIG) Active ingredient: Rabid human immunoglobulin Specification: 200 IU / 2 ml / bottle Administration mode: intramuscular injection of the vastus lateral muscle group. Usage and dosage: the injection dose was calculated according to the body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site and at least 2.5 cm apart

    Drug: Rabies Human Immunoglobulin (HRIG) · Biological: Lyophilized rabies vaccine for human use (Vero cells)

Interventions

  • DrugNatural full human monoclonal antibody CBB 1 injection 50.0µg/kg

    Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

  • DrugNatural full human monoclonal antibody CBB 1 injection 100.0µg/kg

    Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

  • DrugRabies Human Immunoglobulin (HRIG)

    Active ingredient: Rabid human immunoglobulin

  • Active ingredient: inactivated rabies virus fixed poison

06

What researchers measure

Primary outcomes

  1. Rabia for neutralizing antibody activity

    Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication.

    Time frame: 7 Days

Secondary outcomes

  1. Rabia for neutralizing antibody activity

    RVNA detection rate at days 0.5,1,2,3,5,7,14,28,42,84, and 105 after drug administration. Geometric mean concentration and relative antibody positive rate at days 0.5,1,2,3,5,105,28,42,84,105 (RVNA 0.5 IU / ml).

    Time frame: 105 Days

  2. Safety evaluation index

    Clinical indicators:Physical examination.

    Time frame: 105 Days

  3. Safety evaluation index

    Vital signs: ear temperature/℃

    Time frame: 105 Days

  4. Safety evaluation index

    Vital signs: blood pressure (sitting position)/mmHg

    Time frame: 105 Days

  5. Safety evaluation index

    Vital signs: pulse rate/Time / minute.

    Time frame: 105 Days

  6. Safety evaluation index

    12-lead ECG all were abnormal and clinically significant by the investigator

    Time frame: 105 Days

  7. Safety evaluation index

    local reaction;constitutional reaction.

    Time frame: 105 Days

  8. Safety evaluation index

    Laboratory indicator all were abnormal and clinically significant by the investigator

    Time frame: 105 Days

  9. Immunogenicity evaluation index

    Positive rate of anti-drug antibodies (ADA) on days 14,28,84,105 after administration. If ADA positive, continue to evaluate whether it is rabies mAb CBB 1 neutralizing antibody

    Time frame: 105 Days

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for May 2025, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2024
First posted
Aug 12, 2024
StartEst.
Jul 31, 2024
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2025
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06548139
Lead sponsor
Changchun BCHT Biotechnology Co.
Collaborators
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Anning City First People's Hospital, Yunnan Central Hospital, Beijing Contreke Statistical Technology Co., LTD, Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Jul 31, 2024 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Aug 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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