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
Abstract
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.
Conditions: Healthy Volunteers.
Primary outcome: AEs; Number of participants with clinically significant abnormality in physical examinations; Change in Hematocrit (ratio); Change in Haemoglobin (g/L); Change in Platelet count (cells x 10^9/L); Change in Red blood cell count (cells x 10^12/L); Change in differential leukocyte count (cells x 10^9/L); Change in Serum Alanine Aminotransferase (ALT) (U/L); Change in Serum Aspartate Aminotransferase (AST) (U/L); Change in Serum Albumin (g/L); Change in Serum Alkaline Phosphatase (ALP) (U/L); Change in Serum Total Bilirubin (umol/L); Change in Serum Blood urea nitrogen (BUN) (mmol/L); Change in Serum Creatinine (umol/L); Change in Serum Calcium (mmol/L); Change in Serum Chloride (mmol/L); Change in Serum Cholesterol (mmol/L); Change in Serum Creatine Kinase (U/L); Change in Serum Glucose (mmol/L); Change in Serum Lactate Dehydrogenase (U/L); Change in Serum Phosphorus (mmol/L); Change in Serum Potassium (mmol/L); Change in Serum Total protein (g/L); Change in Urine Bilirubin (U-BIL); Change in Urine Glucose (GLU) (mg/dL); Change in Urine erythrocytes (U-RBC); Change in Urinary leukocyte (U-LEU); Change in Urine nitrites (U-NIT); Change in Urine protein (U-PRO); Change in Urine specific gravity (U-SG); Change in Urine urobilinogen (URO); Change…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 28 participants or records.
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