A randomized, double-blind, placebo-controlled, single/multiple dose study of recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, tolerability and pharmacokinetics
This is a randomized, double-blind, placebo-controlled, single / multiple dose trial. recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, and pharmacokinetics.The volunteers will be given the drug by intramuscular injection. The main purpose of this trial is to investigate the safety, tolerability , pharmacokinetics and immunogenicity of Chinese healthy volunteers after intramuscular injection of recombinant human nerve growth factor injection, to provide a safe dose range for subsequent clinical trials, as well as a safe and reasonable drug delivery program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
Intramuscular injection once on the first day according to dose requirements
Intramuscular injection once on the first day according to dose requirements
Intramuscular injection once daily for 7 days according to dose requirements
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of adverse events
Record the number of participants with abnormal laboratory values and/or adverse events,calculate frequency and percentage based on correlation with the investigational drug.
Time frame: Single dose: 28 days / Multiple dose: 34 days
Area under curve (AUC) after injection of single dose/multiple dose
To measure the drug concentration in blood samples which collected after injection
Time frame: Single dose: 24 hours / Multiple doses: 8 days
Cmax after injection of single dose/multiple dose
To measure the drug concentration in blood samples which collected after injection
Time frame: Single dose: 24 hours / Multiple doses: 8 days
Tmax after injection of single dose/multiple dose
To measure the drug concentration in blood samples which collected after injection
Time frame: Single dose: 24 hours / Multiple doses: 8 days
T1/2 after injection of single dose/multiple dose
To measure the drug concentration in blood samples which collected after injection
Time frame: Single dose: 24 hours / Multiple doses: 8 days
Percentage of Participants With anti-drug antibodies
Percentage of participants with treatment-emergent positive anti-drug antibodies was summarized by treatment group.
Time frame: Single dose: 28 days / Multiple dose: 34 days
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