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RAB001(LLP2A-Ale) in Healthy Subjects
Sponsor: ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Summary
This trial is a single center, randomized, double-blind, placebo-controlled dose escalation study aimed at examining the safety, tolerability, and pharmacokinetics/pharmacodynamics of single and multiple injections of RAB001 in healthy subjects. According to the results of Phase I clinical trials abroad, two dose groups (400 μ g/kg and 750 μ g/kg) were established, with 8 healthy subjects enrolled in each dose group (6 in the experimental group and 2 in the placebo group), for a total of 16 healthy subjects. Each dose group is divided into two stages. Phase 1: Single dose administration phase Subjects who meet the inclusion criteria will first undergo a single dose study in the 400 μ g/kg dose group. Blood samples will be collected at predetermined time points for single dose PK, PD, and immunogenicity evaluation. After the single dose, safety and tolerance data will be collected for 14 days. If the subjects are tolerant, a single dose study in the 750 μ g/kg dose group can be conducted. After the dose increases to the maximum dose of 750 μ g/kg as designed in this experiment, the next dose will not be administered. Phase 2: Multiple administration phase Single dose administration is combined with multiple dose administration. If the subjects can tolerate it during the single dose phase, they will enter the multiple dose study phase, which will be administered once every 2 weeks, on days 15, 29, and 43 respectively. Collect blood samples at predetermined time points for PK, PD, and immunogenicity evaluation, observe for 14 days after the last administration, and collect safety and tolerability data. This experiment adopts a step-by-step increasing method for dose escalation, and the next dose group must complete the safety and tolerability evaluation of a single dose in the previous dose group before starting. Each subject only receives one corresponding dose.
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RAB001 in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2023-02-10
Completion Date
2023-07-05
Last Updated
2026-04-22
Healthy Volunteers
Yes
Conditions
Interventions
RAB001 400 μg/kg group
The subjects received intravenous administration of RAB001 400 μ g/kg on day 1、15、29、43
RAB001 750 μg/kg group
The subjects received intravenous administration of RAB001 750 μ g/kg on day 1、15、29、43
Normal saline
The subjects received intravenous administration of normal saline on day 1、15、29、43
Locations (1)
Hebei University Affiliated Hospital
Baoding, Hebei, China