The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
A single dose of LP-005 (Dose 1) was administered intravenously.
A single dose of LP-005 (Dose 2) was administered intravenously.
A single dose of LP-005 (Dose 3) was administered intravenously.
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Adverse events
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Time frame: Observation for 78 days after administration
Time to peak concentration (Tmax) of LP-005
The time when the blood drug concentration reaches its peak after a single dose of medication.
Time frame: Observation for 78 days after administration
Maximum concentration (Cmax) of LP-005
The maximum concentration of LP-005 in the bloodstream after administration.
Time frame: Observation for 78 days after administration
Elimination half-life (t1/2) of LP-005
The time required for the concentration of LP-005 in the bloodstream to decrease by half.
Time frame: Observation for 78 days after administration
Area under the concentration-time curve (AUC0-t) of LP-005
The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration.
Time frame: Observation for 78 days after administration
Apparent clearance rate (CL/F) of LP-005
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Time frame: Observation for 78 days after administration
Assessment of immunogenicity
The proportion of anti drug antibody (ADA) positive subjects at different detection time points.
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A single dose of LP-005 (Dose 4) was administered intravenously.
A single dose of LP-005 (Dose 5) was administered intravenously.
A single dose of LP-005 (Dose 6) was administered intravenously.
A single dose of placebo was administered intravenously.
LP-005 (Dose 7) was administered multiple times intravenously.
LP-005 (Dose 8) was administered multiple times intravenously.
LP-005 (Dose 9) was administered multiple times intravenously.
Placebo was administered multiple times intravenously.
Time frame: Observation for 78 days after administration
Assessment of complement C5 activity
Evaluate complement C5 hemolytic activity and serum concentration of C5 changes from baseline at various time points of assessment.
Time frame: Observation for 78 days after administration
Assessment of complement C3b activity
Evaluate C3b deposition on red blood cells and serum concentration of C3b changes from baseline at various time points of assessment.
Time frame: Observation for 78 days after administration