Phase Ib Trial of Injectable RAB001 for Knee Osteoarthritis

Sponsor
ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Study ID
NCT07652372
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RAB001 medium dose — DRUG
    Treatment period: 8 weeks, with study medication administered once every 4 weeks for a total of 3 administrations. All injections shall be performed under full aseptic technique. In case of joint effusion, arthrocentesis shall be conducted prior to study drug administration. The study drug will be injected over approximately 30 to 60 seconds. Subjects shall be monitored for 15 to 30 minutes after injection.

Study Details

This is a randomized, double-blind, placebo-controlled dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of intra-articular injection of RAB001 in participants with knee osteoarthritis (KOA). The study consists of five dose groups: 1.5 mg, 4.5 mg, 9 mg, 18 mg and 27 mg. A total of 12 participants with knee osteoarthritis will be enrolled per dose group (9 receiving investigational product and 3 receiving placebo), for an overall total enrollment of 60 subjects. The 27 mg cohort serves as an optional escalation group, whose initiation is contingent upon assessment by the Safety Review Committee (SRC). Eligible participants will first receive a single-dose administration followed by a 14-day observation period, during which safety, tolerability, PK and preliminary efficacy data will be collected. In the multiple-dose phase, study treatment will be administered once every 4 weeks for a total of 2 injections, on Week 4 (Day 29) and Week 8 (Day 57), respectively. After the last administration, subjects will enter the follow-up period and return to the study site for safety and efficacy assessments at Weeks 12, 16 and 24. A staggered dose-escalation design will be implemented. Escalation to the next higher dose level may proceed only after completion of the 14-day safety and tolerability evaluation for all subjects in the current dose cohort and subsequent approval from the SRC. Each participant will receive only one assigned dose level throughout the trial.

Key Dates

First listed
Jun 17, 2026
Start date
Apr 16, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.5 mg
    9 subjects and 3 receive placebo.
  • Experimental: 4.5 mg
    9 subjects and 3 receive placebo.
  • Experimental: 9 mg
    9 subjects and 3 receive placebo.
  • Experimental: 18 mg
    9 subjects and 3 receive placebo.
  • Experimental: 27 mg
    9 subjects and 3 receive placebo.The 27 mg cohort is an optional dose-escalation group, and its implementation will be determined based on the assessment from the Safety Review Committee (SRC).

Primary Outcome Measure

Efficacy Endpoints-(WOMAC A1) [ Time Frame: Weeks 4, 8, 12, 16 and 24 ]

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