RAB001 Phase 1, Osteonecrosis, 16 Healthy Subjects
Summary
A Phase 1 clinical trial for RAB001 (LLP2A-Ale) has been registered on ClinicalTrials.gov (NCT07545018) examining safety, tolerability, and pharmacokinetics in 16 healthy subjects across two dose groups (400 μg/kg and 750 μg/kg) for the treatment of Osteonecrosis of the Femoral Head. The single-center, randomized, double-blind, placebo-controlled dose escalation study includes both single-dose and multiple-dose phases with injections administered once every 2 weeks.
“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.”
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What changed
This document registers a new Phase 1 clinical trial (NCT07545018) for RAB001, an investigational drug for Osteonecrosis of the Femoral Head, on ClinicalTrials.gov. Based on prior Phase I clinical trial results abroad, the trial will enroll 16 healthy subjects split across two dose escalation groups (400 μg/kg and 750 μg/kg), with 6 active and 2 placebo subjects per group. The study proceeds in single-dose and multiple-dose phases with 14-day observation periods.
For pharmaceutical companies and clinical investigators, this registration signals active development of RAB001 for a degenerative bone condition affecting the femoral head. The dose-escalation design and immunogenicity assessments indicate standard Phase 1 safety profiling following foreign preliminary data. Sponsors considering competing programs for osteonecrosis or similar orthopedic indications should monitor this trial's progression.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
RAB001（LLP2A-Ale） in Healthy Subjects
Phase 1 NCT07545018 Kind: PHASE1 Apr 22, 2026
Abstract
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...
Conditions: Osteonecrosis of the Femoral Head
Interventions: RAB001 400 μg/kg group, RAB001 750 μg/kg group, Normal saline
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