This is a single-center, randomized, double-blind, does-escalation Phase I Clinical Study that aim to evaluate the tolerability, safety and PK Characteristics of recombinant humanized CTLA-4-FC fusion protein injection in Healthy Subjects.
This study adopts a single-center,randomized, double-blind, does-escalation, placebo-controlled design. There are five dose levels of 1mg/kg, 2.5mg/kg, 5mg/kg, 7.5mg/kg and10mg/kg. 2 of 4 subjects in the 1mg/kg dose group receive the test drug and two receive a placebo. 4 of 6 subjects in the 2.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 7.5mg/kg dose group receive the test drug and two receive a placebo. 10 of 12 subjects in the 10mg/kg dose group receive the test drug and two receive a placebo. Subjects are randomly assigned to receive intravenous administration of the test drug or placebo. The next higher dose group could be initiated only if the stopping rules is not met which are determined by investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage.
Peking University People's Hospital
Beijing, China
RECRUITINGSafety as measured by subjects with adverse events
The number of occurrences and incidence are calculated with vital signs, Electrocardiograms, physical examinations, laboratory tests
Time frame: First dose up to last follow-up visit (85 days after administration)
Peak concentration (Cmax)
Maximum plasma concentration (Cmax) of CTLA-4-FC fusion protein
Time frame: First dose up to last follow-up visit(Day1-Day85)
Peak time (Tmax)
Time required to reach peak concentration after administration of CTLA-4-FC fusion protein
Time frame: First dose up to last follow-up visit(Day1-Day85)
Area under the Curve (AUC)
Time required to reach peak concentration after administration of CTLA-4-FC fusion protein
Time frame: First dose up to last follow-up visit(Day1-Day85)
Analysis of immunogenicity
The number and positive percentage of anti-drug antibody(ADA) and Neutralizing Antibody(NAb) in different dose groups (experimental drug group and placebo group) were calculated
Time frame: First dose up to last follow-up visit(Day1-Day85)
Yi Fang, Phd
CONTACT
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Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg