Multicenter, Randomized, Blinded, Controlled Phase I / Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination
Overview
- Phase
- Early Phase 1
- Intervention
- Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation
- Conditions
- Clostridium Tetanus
- Sponsor
- Changchun BCHT Biotechnology Co.
- Enrollment
- 190
- Primary Endpoint
- Safety evaluation index
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
Detailed Description
Ia (separate administration phase) To evaluate the safety and tolerability of a single intramuscular injection of different doses of CBL8851 injection in healthy adult Chinese volunteers. 1. To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers; 2. To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers; 3. To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of CBL8851 injection in Chinese healthy adult volunteers. Ib (Drug interaction phase) To evaluate the safety and tolerability of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers. 1. To evaluate the pharmacodynamic characteristics of the intramuscular CBL8851 injection combined with the adsorption of tetanus vaccine in Chinese healthy adult volunteers, and to evaluate the drug interaction; 2. To evaluate the pharmacokinetic characteristics of intramuscular CBL8851 injection plus tetanus vaccine in Chinese healthy adult volunteers; 3. To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection combined with tetanus vaccine in Chinese healthy adult volunteers. II designated time Compare the neutralizing antibody activity of intramuscular CBL8851 injection and tetanus human immunoglobulin in Chinese adult volunteers to select the best dose for subsequent efficacy confirmatory tests. 1. to compare the safety of intramuscular CBL8851 injection with tetanus human immunoglobulin in Chinese adult volunteers; 2. To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection in Chinese adult volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Before the trial, I have a detailed understanding of the nature, significance and possible benefits of the trial, possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, be 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\~59 (including boundary values) at the time of screening;
- •The weight of female volunteers was 45.0 kg, male volunteers were 50.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg / m2 (including the boundary value) (BMI= weight kg / height m2);
- •female volunteers from the 14 days before the first dose to 3 months after the end of the test and voluntary use at least one acceptable contraceptive method, male volunteers from the first time to the trial within 3 months no fertility or donate sperm plan and voluntary use of at least one acceptable contraceptive method.
Exclusion Criteria
- •People who are known to be allergic to experimental drugs (including excipients and similar drugs), or who suffer from severe allergic diseases or allergies (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers by the judgment of the investigator (inquiry);
- •Those with a clear history of allergy to essential substances (such as skin disinfectants and alcohol substances that may be exposed to) during the test (inquiry);
- •tetanus vaccine or tetanus toxin antigen component (DPT vaccine, DPT vaccine, meningitis conjugate vaccine, etc.) vaccinated in the previous 10 years (inquiry);
- •Those who received any live attenuated vaccine or inactivated vaccine (including COVID-19 vaccine) within 1 month (30 days) before the first dose, or received the above vaccine within 3 months after the planned dose (inquiry);
- •Previous history of tetanus infection (inquiry);
- •Known or suspected immune deficiency (inquiry), including immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroid hormones, antimetabolism, cytotoxic drugs) (inquiry, inquiry), HIV infection (inquiry) within 3 months before the first dose (90 days);
- •History of active infection or disease with one of the following conditions:
- •Systemic systemic anti-infective therapy within 14 days before the first administration (inquiry, inquiry); Recurrent, chronic, or other active infections, as assessed by the investigator, may increase the volunteer risk (inquiry).
- •Patients with chronic diseases (including hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.) (phase I only); chronic diseases (including hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.) and unstable control (phase II only) (inquiry);
- •People with a history of tuberculosis who are not cured or have active tuberculosis infection during screening (inquiry);
Arms & Interventions
Experimental group
Each dose (1.0 ml) contained 1.25 mg of fully human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of fully human anti-tetanus toxin monoclonal antibody B86,2.5 mg (1.0 ml) / vial
Intervention: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation
Experimental group
Each dose (1.0 ml) contained 1.25 mg of fully human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of fully human anti-tetanus toxin monoclonal antibody B86,2.5 mg (1.0 ml) / vial
Intervention: Adsorbed tetanus vaccine (TT)
Positive control group
Tetanus with human immunoglobulin
Intervention: Tetanus human immunoglobulin (HTIG)
Positive control group
Tetanus with human immunoglobulin
Intervention: Adsorbed tetanus vaccine (TT)
Placebo group
There were no active ingredients, and other ingredients were the same
Intervention: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo
Placebo group
There were no active ingredients, and other ingredients were the same
Intervention: Adsorbed tetanus vaccine (TT)
Outcomes
Primary Outcomes
Safety evaluation index
Time Frame: Twelve months
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 tests: blood routine, urine routine, blood biochemistry (liver function, kidney function, fasting blood glucose, blood lipid, myocardial enzyme spectrum, electrolytes), blood coagulation routine, blood / urine pregnancy test (only fertility women), etc.; Other auxiliary examinations: chest CT and abdominal B-ultrasound.
Secondary Outcomes
- PD evaluation index(Twelve months)
- Immunogenicity evaluation index(Twelve months)
- PK evaluation index(Twelve months)