Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-07
Brief Title:
Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 B86 Injection Combination Formulation
Sponsor:
Changchun BCHT Biotechnology Co
Organization:
Changchun BCHT Biotechnology Co
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None