The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 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-003 and Part 2, multiple ascending dose (MAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
A single dose of LP-003 (Dose 1) was administered intravenously.
A single dose of LP-003 (Dose 2) was administered intravenously.
A single dose of LP-003 (Dose 3) was administered intravenously.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Adverse events
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Time frame: Observation for 280 days after administration
Time to peak concentration (Tmax) of LP-003
The time when the blood drug concentration reaches its peak after a single dose of medication.
Time frame: Observation for 280 days after administration
Maximum concentration (Cmax) of LP-003
The maximum concentration of LP-003 in the bloodstream after administration.
Time frame: Observation for 280 days after administration
Elimination half-life (t1/2) of LP-003
The time required for the concentration of LP-003 in the bloodstream to decrease by half.
Time frame: Observation for 280 days after administration
Area under the concentration-time curve (AUC0-t) of LP-003
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 280 days after administration
Apparent clearance rate (CL/F) of LP-003
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Time frame: Observation for 280 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-003 (Dose 4) was administered intravenously.
A single dose of LP-003 (Dose 5) was administered intravenously.
A single dose of placebo was administered intravenously.
LP-003 (Dose 6) was administered multiple times subcutaneously.
LP-003 (Dose 7) was administered multiple times subcutaneously.
LP-003 (Dose 8) was administered multiple times subcutaneously.
Placebo was administered multiple times subcutaneously.
Time frame: Observation for 280 days after administration
Assessment of total immunoglobulin E (IgE)
The changes in serum total immunoglobulin E (IgE) levels compared to baseline at different assessment time points.
Time frame: Observation for 168 days after administration
Assessment of free IgE
The changes in serum free IgE levels compared to baseline at different assessment time points.
Time frame: Observation for 168 days after administration