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

NCT05832073 | Unknown Early Phase 1

• 1 other identifier: B1801-F20220210
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rabies Virus Infection

Keywords

Safety; Immunogenicity; Rabies Virus Neutralizing Antibodies

Outcome Measures

Primary Outcomes (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).

  Twelve months

Secondary Outcomes (8)

• PK evaluation index

  Twelve months

• PK evaluation index

  Twelve months

• PK evaluation index

  Twelve months

• PK evaluation index

  Twelve months

• PK evaluation index

  Twelve months

Study Arms (3)

Experimental group

EXPERIMENTAL

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; Biological: Lyophilized rabies vaccine for human use (Vero cells)

Positive control group

ACTIVE COMPARATOR

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)

Placebo group

PLACEBO COMPARATOR

Healthy people in placebo group will receive a dose of placebo

Drug: Natural full human monoclonal antibody CBB 1 injection placebo; Biological: Lyophilized rabies vaccine for human use (Vero cells)

Interventions

Natural full human monoclonal antibody CBB 1 injection DRUG

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

Experimental group

Rabies Human Immunoglobulin (HRIG) DRUG

Active ingredient: Rabid human immunoglobulin

Positive control group

Natural full human monoclonal antibody CBB 1 injection placebo DRUG

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

Placebo group

Lyophilized rabies vaccine for human use (Vero cells) BIOLOGICAL

Active ingredient: inactivated rabies virus fixed poison

Experimental group; Placebo group; Positive control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine: collaborator
• Anning City First People's Hospital: collaborator
• Beijing Contreke Statistical Technology Co., LTD: collaborator
• Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD: collaborator

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The design of this trail is based on random, two-blind, placebo control. The subjects and investigators will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 27, 2023
• Study Start: April 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (1)