Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation

NCT06360250 | Not Yet Recruiting Early Phase 1

• 1 other identifier: B2001-F20220601
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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

Conditions

Clostridium Tetanus

Keywords

Monoclonal antibody to tetanus; Safety; tolerability; pharmacokinetics; pharmacodynamics; immunogenicity

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 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.

  Twelve months

Secondary Outcomes (10)

• 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

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

Drug: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation; Biological: Adsorbed tetanus vaccine (TT)

Positive control group

ACTIVE COMPARATOR

Tetanus with human immunoglobulin

Drug: Tetanus human immunoglobulin (HTIG); Biological: Adsorbed tetanus vaccine (TT)

Placebo group

PLACEBO COMPARATOR

There were no active ingredients, and other ingredients were the same

Drug: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo; Biological: Adsorbed tetanus vaccine (TT)

Interventions

Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation DRUG

Each dose (1.0 ml) contained 1.25 mg of human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of human anti-tetanus toxin monoclonal antibody B86.

Experimental group

Tetanus human immunoglobulin (HTIG) DRUG

Tetanus human immunoglobulin (HTIG)

Positive control group

Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo DRUG

There were no active ingredients, and other ingredients were the same

Placebo group

Adsorbed tetanus vaccine (TT) BIOLOGICAL

containing tetanus toxoid titer not less than 40 IU

Experimental group; Placebo group; Positive control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• has a history of malignancy (active or has been treated but not clearly clinically cured, or may recur during the trial) (inquiry);
• Patients with a previous history of convulsions, epilepsy, mental or neurological system, or a family history of convulsions or epilepsy (inquiry);
• Those who have a history of clinically serious disease within 6 months before the first dose (180 days) and are not cured, or those who have acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the investigational drug (inquiry, inquiry);
• Those who had received major surgery within 3 months (90 days) prior to the first dose, or who may have significantly affected the process or safety evaluation of the study drug, or who planned to undergo surgery during the study (inquiry, inquiry);
• Those who have been used or are in significant impact on the in vivo process or safety evaluation of the investigational drug (inquiry, 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

Central Study Contacts

Jianchang HJC He

CONTACT

China：+86-6363-6790; hejc@yn-cprc.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: April 10, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04