Clinical trial NCT05625477: Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Dose-Finding Phase II Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo Following a Single Intramuscular Injection in Chinese Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tetanus
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.


Eligibility criteria: Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years;
2. Healthy volunteers or volunteers with stable chronic diseases;
3. Volunteers who provide signed written informed consent form.

Exclusion Criteria:

1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
3. History of alcohol or other substance abuse.

Primary outcomes:
measure: Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
timeFrame: At 24 hours post-dose
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 105 days post dosing
measure: Change from baseline in anti-tetanus neutralizing antibody titers (∆ titers)
timeFrame: At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
measure: Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
timeFrame: At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
measure: Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose
timeFrame: Up to 105 days post dosing
measure: Maximum concentration (Cmax) of TNM002
timeFrame: Up to 105 days post dosing
measure: Time to maximum concentration (Tmax) of TNM002
timeFrame: Up to 105 days post dosing
measure: Elimination half-life (T1/2) of TNM002
timeFrame: Up to 105 days post dosing
measure: Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002
timeFrame: Up to 105 days post dosing
measure: Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002
timeFrame: Up to 105 days post dosing
measure: Positive rate of ADA in volunteers in TNM002 groups
timeFrame: Up to 105 days post dosing
Other outcomes:
Locations:
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
city: Kunming
country: China
facility: Yunnan Provincial Hospital of Traditional Chinese Medicine
state: Yunnan
Study officials:
affiliation: Peking University Care Luzhong Hospital
name: Jie Hou
role: PRINCIPAL_INVESTIGATOR
References: