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Rabies Virus InfectionEarly Phase 1NCT05832073

Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1

A Early Phase 1 study testing Natural full human monoclonal antibody CBB 1 injection, Rabies Human Immunoglobulin (HRIG) and Lyophilized rabies vaccine for human use (Vero cells) in people with Rabies Virus Infection, run by Changchun BCHT Biotechnology Co. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Rabies Virus Infection
What is being tested?
Natural full human monoclonal antibody CBB 1 injection, Rabies Human Immunoglobulin (HRIG) and Lyophilized rabies vaccine for human use (Vero cells)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteChina
Study dates
30 Apr 2023to 30 Apr 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 informed consent;
  • Men or women aged 18~50 (including boundary values) at the time of screening;
  • 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 body mass index (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
  • 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 contraception, 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.

Who cannot join

  • Those who are known to be allergic to the study drug (including excipients, 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);
  • Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
  • 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);
  • Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
  • Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
  • 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);
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  • Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);
  • 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);
  • Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);
  • Those who have used a rabies passive immunization preparation or used systemic immunosuppressive agents such as glucocorticoids within 3 months (90 days) prior to the first dose (inquiry, inquiry)；
  • 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);
  • 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);
  • 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);
  • Those with positive alcohol breath test or test value> 0 mg / 100 ml (examination);
  • Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);
  • 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);
  • Those who ingested alcohol-containing products within 24 hours before the first dose (inquiry);
  • 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);
  • Those with a history of substance abuse (inquiry);
  • Those who are screened positive for substance abuse during the screening period (examination);
  • Those who are positive for the initial HIV screening during the screening period (screening);
  • two half and half qualitative tests of hepatitis B during the screening period (examination);
  • Patients with positive results for hepatitis C virus antibody or treponema pallidum antibody during the screening period (examination);
  • Physical examination, vital signs (respiration, blood pressure, pulse rate), electrocardiogram, other laboratory tests (laboratory tests not listed separately) or other auxiliary examination results are judged as abnormal and clinically significant by the study doctor (examination);
  • Ear temperature during the screening period is> 37.5℃ (examination);
  • Women currently in pregnancy or lactation (inquiry);
  • Positive screening pregnancy test (examination);
  • Patients with a history of needle acupuncture, blood sickness, or unable to tolerate venipuncture (inquiry);
  • The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

    Kunming, Yunnan, 650000

    Jianchang He

Other trials in China

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo / Positive Control Evaluation of the First Safety, Pharmacokinetic and Pharmacodynamic Phase I Clinical Trial of Rabies Monomab CBB 1 in Healthy People

rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults

Read the detailed description
  1. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity of rabies virus after single doses of rabies mAb CBB 1 or rabies human immunoglobulin (HRIG) in healthy adults.
  2. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity characteristics of rabies virus after different doses of rabies mAb CBB 1 combination vaccine or HRIG combination vaccine in healthy adults.
  3. Comparison of different doses of rabies mAb CBB 1 alone, different doses of rabies mAb CBB 1, combination vaccine or HRIG combination vaccine used in healthy adults after safety, tolerability, pharmacokinetics, rabies virus neutralization antibody activity and immunogenicity characteristics, further evaluation of drug interaction, for subsequent clinical trials to explore the optimal dose.
Being tested
Natural full human monoclonal antibody CBB 1 injection, Rabies Human Immunoglobulin (HRIG), Natural full human monoclonal antibody CBB 1 injection placebo, Lyophilized rabies vaccine for human use (Vero cells)
Keywords
Safety, Immunogenicity, Rabies Virus Neutralizing Antibodies
Medical subject headings
Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural full human monoclonal antibody CBB 1 injectionDrug

    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

  • Rabies Human Immunoglobulin (HRIG)Drug

    Active ingredient: Rabid human immunoglobulin

  • Natural full human monoclonal antibody CBB 1 injection placeboDrug

    Composition: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

  • Lyophilized rabies vaccine for human use (Vero cells)Biological

    Active ingredient: inactivated rabies virus fixed poison

Study groups in NCT05832073
Study groupRoleWhat they receive
Experimental groupExperimentalNatural 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.
Receives: Drug: Natural full human monoclonal antibody CBB 1 injection; Biological: Lyophilized rabies vaccine for human use (Vero cells)
Positive control groupActive comparatorRabies 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
Receives: Drug: Rabies Human Immunoglobulin (HRIG); Biological: Lyophilized rabies vaccine for human use (Vero cells)
Placebo groupPlacebo comparatorHealthy people in placebo group will receive a dose of placebo
Receives: Drug: Natural full human monoclonal antibody CBB 1 injection placebo; Biological: Lyophilized rabies vaccine for human use (Vero cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety evaluation index

    All observed adverse events, serious adverse events, including but not limited to:

    Clinical indicators Physical examination; vital signs; 12-lead ECG; local reaction; systemic reaction.

    Laboratory indicators Laboratory tests: blood routine, urine routine, blood biochemistry (including liver function, fasting blood glucose, renal function, blood lipid, myocardial enzyme spectrum and electrolyte), blood coagulation routine, viral serology (hepatitis B two half, hepatitis C virus antibodies, human immunodeficiency virus antibodies and treponema antibodies), blood / urine pregnancy test (fertility only women); other auxiliary tests: chest radiograph (positive) and abdominal B ultrasound (including liver, gallbladder, pancreas, spleen and kidney).

    Measured: Twelve months

Secondary outcomes (8)

  1. PK evaluation index

    (1) PK evaluation index Peak Plasma Concentration (Cmax)

    Measured: Twelve months

  2. PK evaluation index

    (1) PK evaluation index Area under the plasma concentration versus time curve (AUC)

    Measured: Twelve months

  3. PK evaluation index

    (1) PK evaluation index Maximum peak time (Tmax)

    Measured: Twelve months

  4. PK evaluation index

    (1) PK evaluation index Half-life period(T1/2)

    Measured: Twelve months

  5. PK evaluation index

    (1) PK evaluation index MeanResidenceTime（MRT）

    Measured: Twelve months

  6. PK evaluation index

    (1) PK evaluation index Apparent clearance rate (CL / F)

    Measured: Twelve months

  7. PD evaluation index

    (2) PD evaluation index Positive rate of RVNA antibody on days 1,3,5,7,14,28 and 42 after medication (percentage of GMT 0.5 IU / ml volunteers); Neutralising antibody (RVNA) activity at days 0.5,1,2,3,5,7,10,14,1,21,28,42,56,84 and 105 after administration.

    Measured: Twelve months

  8. Immunogenicity evaluation index

    (3) Immunogenicity evaluation index ADA positivity on days 14,28,56 and 105 after administration. If ADA positive, they will continue to be evaluated as rabies mAb CBB 1 neutralizing antibody.

    Measured: Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start30 Apr 2023 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
There were 152 healthy people aged 10-50 years, divided into two test groups: 76 rabies mAb CBB 1 alone and 76 rabies mAb CBB 1 combined with rabies vaccine administration, which were divided into 4 groups according to different doses
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832073
Sponsor's protocol ID
B1801-F20220210
Status last verified
Apr 2023
First submitted
22 Mar 2023
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Natural full human monoclonal antibody CBB 1 injection, Rabies Human Immunoglobulin (HRIG) and Lyophilized rabies vaccine for human use (Vero cells) in people with Rabies Virus Infection, run by Changchun BCHT Biotechnology Co. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation index (time frame: Twelve months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

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