Trials / Enrolling By Invitation
Enrolling By InvitationNCT07149454
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection in Healthy Participants
- Status
- Enrolling By Invitation
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus toxin Monoclonal Antibody Injection in Healthy Participants.
Detailed description
The primary objective of the study ： evaluate the safety and tolerability of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants. The secondary objectives are: 1. to evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 2. to evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 3. to evaluate the immunogenicity of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection | intramuscular injection |
| DRUG | Human Tetanus Immunoglobulin | intramuscular injection |
| DRUG | Placebo | intramuscular injection |
Timeline
- Start date
- 2025-08-18
- Primary completion
- 2026-05-27
- Completion
- 2026-06-24
- First posted
- 2025-09-02
- Last updated
- 2026-01-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07149454. Inclusion in this directory is not an endorsement.