Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Re… (NCT07149454) | Clinical Trial Compass
By InvitationPhase 1
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
China68 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Participants voluntarily agree to participate in the study and sign the informed consent form (ICF);
✓. Aged 18-60 years (inclusive) at the time of ICF signing, regardless of gender, with valid legal identification;
✓. Body weight ≥45.0 kg for female participants and ≥50.0 kg for male participants, with a body mass index (BMI) between 18.0 and 28.0 kg/m² (inclusive) (BMI = weight \[kg\]/height \[m²\]);
✓. Female participants of childbearing potential must have no plans for pregnancy or egg donation during the trial and for 6 months after investigational product administration and must voluntarily use at least one effective contraceptive method. Male participants must have no plans for pregnancy or sperm donation during the trial and for 6 months after investigational product administration, and either the male participant or his female partner of childbearing potential must voluntarily use at least one effective contraceptive method.
Exclusion criteria
✕. Known allergy to the investigational product (including excipients or similar drugs), or documented hypersensitivity to essential materials used in the trial (e.g., skin disinfectants); or history of severe allergic diseases, hypersensitivity to monoclonal antibodies, or allergic constitution deemed by investigators to compromise participant safety;
✕. Acute/chronic medical conditions that may significantly affect drug metabolism or safety assessments per investigator judgment;
✕. History of autoimmune diseases or immunodeficiency disorders (including HIV-positive screening);
✕. Chronic hepatitis B/C (HBsAg or HCV antibody-positive during screening);
What they're measuring
1
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Timeframe: 105 days
2
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Timeframe: 105Days
3
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Timeframe: 105Days
4
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Timeframe: 105Days
5
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Timeframe: 105Days
6
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Timeframe: 105Days
7
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Trial details
NCT IDNCT07149454
SponsorLanzhou Institute of Biological Products Co., Ltd