This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.In this trial, four dose groups were preset. The initial dose and dose level were relatively low. Two subjects were planned to be enrolled and only received SSS55 administration. In the subsequent dose group, sentries were set up in each group. In each group, the first two subjects were randomly administered with sentries at a ratio of 1:1 between the test drug SSS55 and the placebo. The sentries were involved in blinding. After the sentries completed the safety assessment 8 days after administration, the remaining subjects in the group were administered in a random ratio between the test drug group and the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
26
SSS55 is an injection targeting complement C3b
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTo evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 22days
To evaluate the pharmacokinetic (PK) characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the AUC of SSS55 injection
Time frame: 22days
To evaluate the pharmacodynamic characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the complement3 of SSS55 injection
Time frame: 22 days
To evaluate the ADA of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the ADA of SSS55 injection
Time frame: 22days
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