By InvitationPhase 1

Phase Ib Trial of Injectable RAB001 for Knee Osteoarthritis

China60 participantsStarted 2026-04-16

Plain-language summary

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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (1) Aged from 40 to 75 years inclusive; (2) Diagnosis of knee osteoarthritis consistent with the diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Osteoarthritis issued by the Joint Surgery Group, Orthopaedic Branch of Chinese Medical Association (2024); (3) Received conservative management (e.g., physical therapy, analgesics) for ≥4 weeks with persistent pain in the target knee; the VAS score of WOMAC Item A1 (walking pain) is ≥40 mm and ≤80 mm at screening and baseline; (4) Target knee is graded as Kellgren-Lawrence Grade I-III; the contralateral knee shall not have a higher KL grade than the target knee. In case of identical grades for both knees, the right knee is defined as the target knee; (5) Body mass index (BMI) ranges from 18 to 30 kg/m² inclusive; (6) Provides written informed consent voluntarily prior to any study-related procedures. Exclusion Criteria: * (1) Unable to ambulate (subjects using walking aids for ≥12 weeks prior to screening visit may continue such aids throughout the study); (2) VAS pain score ≥40 mm in any joint other than the target knee at screening and baseline visits. (3) Subjects with osteoarthritis of the ipsilateral hip; (4) Subjects with substantial target-knee joint effusion judged by the investigator to be ineligible for enrollment; (5) Subjects with active septic arthritis of the target knee, skin breakdown/infection at the injection site, or any significant chronic dermatosis that may i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since RAB001 is injectable and this is a Phase 1 trial, what is known so far about its safety profile, and what kinds of adverse events or serious adverse events should I watch out for if I were to participate?
2The trial is 'enrolling by invitation only' — can you tell me whether I might be a candidate for an invitation, and what criteria are typically used to select participants for a study like this?
3This trial is partly measuring how RAB001 moves through the body — things like how quickly it's absorbed and cleared — which suggests researchers are still establishing basic drug behavior; does that mean there's less certainty about the right dose compared to a later-phase trial, and how does that affect the risk-benefit picture for me?
4The trial measures pain, stiffness, and physical function using the WOMAC scale, but Phase 1 studies are primarily designed to evaluate safety rather than prove the treatment works — so how should I realistically think about the chances of experiencing meaningful symptom relief if I joined?
5Before considering this trial, are there standard treatments for knee osteoarthritis — such as physical therapy, anti-inflammatory medications, or corticosteroid injections — that we haven't fully tried yet and that might be a better starting point for my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy Endpoints-(WOMAC A1)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC Scale A (Pain)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale B (stiffness)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale C (physical function)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale C (physical function)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints

Timeframe: Weeks 4, 8, 12, 16 and 24

Trial details

NCT IDNCT07652372

SponsorZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Efficacy Endpoints-(WOMAC A1)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC Scale A (Pain)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale B (stiffness)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale C (physical function)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints-WOMAC subscale C (physical function)

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints

Timeframe: Weeks 4, 8, 12, 16 and 24

Efficacy Endpoints

Timeframe: Weeks 4, 8, 12, 16 and 24