Clinical trial NCT05842798: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female, 18-55 years of age;
2. Body mass index (BMI) within 19.0-26.0 kg/m2;

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
2. Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
3. History of alcohol or other substance abuse.

Primary outcomes:
measure: AEs
timeFrame: Up to 105 days post dosing
measure: Number of participants with clinically significant abnormality in physical examinations
timeFrame: Up to 105 days post dosing
measure: Change in Hematocrit (ratio)
timeFrame: Up to 105 days post dosing
measure: Change in Haemoglobin (g/L)
timeFrame: Up to 105 days post dosing
measure: Change in Platelet count (cells x 10^9/L)
timeFrame: Up to 105 days post dosing
measure: Change in Red blood cell count (cells x 10^12/L)
timeFrame: Up to 105 days post dosing
measure: Change in differential leukocyte count (cells x 10^9/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Alanine Aminotransferase (ALT) (U/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Aspartate Aminotransferase (AST) (U/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Albumin (g/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Alkaline Phosphatase (ALP) (U/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Total Bilirubin (umol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Blood urea nitrogen (BUN) (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Creatinine (umol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Calcium (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Chloride (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Cholesterol (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Creatine Kinase (U/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Glucose (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Lactate Dehydrogenase (U/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Phosphorus (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Potassium (mmol/L)
timeFrame: Up to 105 days post dosing
measure: Change in Serum Total protein (g/L)
timeFrame: Up to 105 days post dosing
measure: Change in Urine Bilirubin (U-BIL)
timeFrame: Up to 105 days post dosing
measure: Change in Urine Glucose (GLU) (mg/dL)
timeFrame: Up to 105 days post dosing
measure: Change in Urine erythrocytes (U-RBC)
timeFrame: Up to 105 days post dosing
measure: Change in Urinary leukocyte (U-LEU)
timeFrame: Up to 105 days post dosing
measure: Change in Urine nitrites (U-NIT)
timeFrame: Up to 105 days post dosing
measure: Change in Urine protein (U-PRO)
timeFrame: Up to 105 days post dosing
measure: Change in Urine specific gravity (U-SG)
timeFrame: Up to 105 days post dosing
measure: Change in Urine urobilinogen (URO)
timeFrame: Up to 105 days post dosing
measure: Change in Prothrombin time (sec)
timeFrame: Up to 105 days post dosing
measure: Change in Activated partial thromboplastin time (APTT)(sec)
timeFrame: Up to 105 days post dosing
measure: Change in fibrinogen (g/L)
timeFrame: Up to 105 days post dosing
measure: Change in international normalized ratio (INR
timeFrame: Up to 105 days post dosing
measure: Change in RR intervals (msec)
timeFrame: Up to 105 days post dosing
measure: Change in PR intervals (msec)
timeFrame: Up to 105 days post dosing
measure: Change in QRS duration (msec)
timeFrame: Up to 105 days post dosing
measure: Change in QT intervals (msec)
timeFrame: Up to 105 days post dosing
measure: Change in QTcB intervals (msec)
timeFrame: Up to 105 days post dosing
measure: Change in QTcF intervals (msec)
timeFrame: Up to 105 days post dosing
measure: Change in blood pressure (mmHg)
timeFrame: Up to 105 days post dosing
measure: Change in pulse rate (bpm)
timeFrame: Up to 105 days post dosing
measure: Change in body temperature (celsius)
timeFrame: Up to 105 days post dosing
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 105 days post dosing
measure: Time of maximum plasma concentration (Tmax)
timeFrame: Up to 105 days post dosing
measure: Terminal half-life (T1/2)
timeFrame: Up to 105 days post dosing
measure: Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
timeFrame: Up to 105 days post dosing
measure: Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
timeFrame: Up to 105 days post dosing
measure: Apparent total body clearance (CL/F)
timeFrame: Up to 105 days post dosing
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to 105 days post dosing
measure: Anti-TNM002 antibodies
timeFrame: Up to 105 days post dosing
measure: Anti-TNM002 antibodies
timeFrame: Up to 105 days post dosing
Other outcomes:
measure: Tetanus-antibody titer
timeFrame: Up to 105 days post dosing
measure: Tetanus-antibody titer
timeFrame: Up to 105 days post dosing
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Fifth Affiliated Hospital, Sun Yat-sen University
name: Zhigang Liu
role: PRINCIPAL_INVESTIGATOR
References: