Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT06360250
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.
Study:
NCT06360250
Study Brief:
Protocol Section:
NCT06360250