Knee OsteoarthritisPhase 1LBRC_RAB001_OANCT07652372
Phase Ib Trial of Injectable RAB001 for Knee Osteoarthritis
A Phase 1 study testing RAB001 medium dose in people with Knee Osteoarthritis, run by ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd. at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- RAB001 medium dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 16 Apr 2026to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
- 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 interfere with intra-articular injection and/or injection-site safety assessment; (6) Subjects unable to discontinue permitted analgesics within 48 hours prior to efficacy assessments; (7) Subjects receiving systemic corticosteroids within 12 weeks before screening; (8) Subjects with septic arthritis in any joint within 12 weeks before screening; (9) Subjects exposed to any investigational medicinal product, device or biologic within 12 weeks before screening; (10) Subjects receiving intra-articular corticosteroid injection into the target knee within 24 weeks before screening; (11) Subjects receiving viscosupplementation injection (sodium hyaluronate, medical chitosan) in the target knee within 24 weeks before screening; (12) Subjects who underwent major lower-extremity surgery, arthroplasty or arthroscopy on target knee or other lower-limb joints within 24 weeks before screening, or with planned lower-limb surgery during study period; (13) Subjects with secondary knee osteoarthritis induced by acute disease or trauma within 5 years before screening; (14) Subjects with active malignancy or history of anti-tumor therapy within 5 years before screening, excluding non-melanoma skin cancer; (15) Subjects with inflammatory arthropathies or relevant disorders involving joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gout, symptomatic chondrocalcinosis, osteonecrosis or active infection); (16) Subjects with marked varus/valgus deformity, ligamentous laxity or unstable meniscus; (17) Subjects with chronic painful conditions (VAS ≥40 mm) at screening or peripheral/central neuropathy impairing sensory function around target knee, including but not limited to back pain, hip pain, intervertebral disc herniation, sciatica, diabetic neuropathy, post-stroke pain or fibromyalgia; (18) Subjects with pulmonary diseases such as asthma or COPD requiring regular systemic/inhaled corticosteroid treatment during study; (19) Subjects with venous or lymphatic stasis of lower extremities; (20) Subjects with claudication or peripheral arterial disease; (21) Subjects on ongoing oral/parenteral anticoagulation or high-dose antiplatelet therapy (daily aspirin ≤100 mg and/or antiplatelet agents such as clopidogrel, ticagrelor are permitted); (22) Subjects on chronic regular intake of paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs); (23) Subjects with severe systemic illnesses including myocardial infarction, heart failure, unstable angina, cerebrovascular disease, severe renal insufficiency, etc.; (24) Subjects with severe hepatic impairment or relevant medical history; (25) Subjects with abnormal coagulation parameters; (26) Subjects with known hypersensitivity to any component of investigational product or paracetamol, or severe allergic constitution as assessed by investigator; (27) Female subjects with positive pregnancy test, breastfeeding, unwilling to implement effective contraception or planning pregnancy during trial; (28) Subjects with any other conditions deemed inappropriate for study enrollment by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijin, Beijin, 100730
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Intra-Articular Injection of RAB001 for Injection in Participants With Knee Osteoarthritis
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).
Read more
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- RAB001 medium dose
- Keywords
- knee osteoarthritis, RAB001, LLP2A-Alendronate
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAB001 medium doseDrug
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 group | Role | What they receive |
|---|---|---|
| 1.5 mg | Experimental | 9 subjects and 3 receive placebo. Receives: Drug: RAB001 medium dose |
| 4.5 mg | Experimental | 9 subjects and 3 receive placebo. Receives: Drug: RAB001 medium dose |
| 9 mg | Experimental | 9 subjects and 3 receive placebo. Receives: Drug: RAB001 medium dose |
| 18 mg | Experimental | 9 subjects and 3 receive placebo. Receives: Drug: RAB001 medium dose |
| 27 mg | Experimental | 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). Receives: Drug: RAB001 medium dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoints-(WOMAC A1)
Changes from baseline in the walking pain score of target knee (WOMAC A1). WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints-WOMAC Scale A (Pain)
Change from baseline in target knee WOMAC Scale A (Pain) score at Weeks 4, 8, 12, 16 and 24
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints-WOMAC subscale B (stiffness)
Change from baseline in target knee WOMAC subscale B (stiffness) score at Weeks 4, 8, 12, 16 and 24.
WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints-WOMAC subscale C (physical function)
Change from baseline in target knee WOMAC subscale C (physical function) score at Weeks 4, 8, 12, 16 and 24.
WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints-WOMAC subscale C (physical function)
Change from baseline in target knee total WOMAC score at Weeks 4, 8, 12, 16 and 24.
WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Percentage of responders per( OMERACT-OARSI )response criteria at Weeks 4, 8, 12, 16 and 24
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Changes from baseline in the five KOOS subdomain scores (pain, symptoms, activities of daily living, sport and recreation function, knee-related quality of life) for the target knee at Weeks 4, 8, 12, 16 and 24.
KOOS =Knee injury and Osteoarthritis Outcome Score
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Changes from baseline in Patient Global Assessment (PGA) score at Weeks 4, 8, 12, 16 and 24
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Changes from baseline in Clinician's Global Assessment (COGA) score at Weeks 4, 8, 12, 16 and 24
Measured: Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Cumulative intake of rescue medication (paracetamol / acetaminophen) throughout the study period.
Measured: Day 1 to Week 24
Pharmacokinetic (PK) Endpoints Cmax
Maximum observed plasma concentration
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-AUC₀-ₜ
Area under the concentration-time curve from time 0 to last measurable time point
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-AUC₀-∞
Area under the concentration-time curve from time 0 to infinity
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-AUC_%Extrap
Percentage of AUC extrapolation
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-Tmax
Time to reach maximum concentration
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-t₁/₂z
Terminal elimination half-life
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-Vz/F
Apparent volume of distribution (terminal phase, extravascular route)
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-CLz/F
Apparent total clearance (terminal phase, extravascular route)
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-λz
Terminal elimination rate constant
Measured: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Pharmacokinetic (PK) Endpoints-Css,max
Steady-state maximum concentration
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-Css,min
Steady-state minimum concentration
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-Css,av
Average steady-state concentration
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-AUC₀-τ
Area under the curve over one dosing interval
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-CLss/F
Apparent total clearance at steady state
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-Vz,ss/F
Apparent volume of distribution at steady state
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-Ra(Cmax)
Accumulation ratio of maximum concentration
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-Ra(AUC)
Accumulation ratio of AUC
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Pharmacokinetic (PK) Endpoints-DF
Fluctuation degree / Degree of fluctuation
Measured: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Safety Endpoints-AE(adverse events)
Safety assessments and grading of adverse events (AEs) occurring throughout the study period were performed in accordance with NCI-CTCAE Version 5.0.
Measured: Day 1 to Week 24
Safety Endpoints-SAE(Serious adverse events)
Safety assessed by CTCAE v5.0 of the SAE(Serious adverse events) during the study.
Measured: Day 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start16 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652372
- Sponsor's protocol ID
- LBRC_RAB001_OA_PHI
- Acronym
- LBRC_RAB001_OA
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on a comprehensive consideration of ethical compliance (informed consent), legal constraints, protection of commercial interests, and operational feasibility, individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Intra-Articular Injection of RAB001 for Injection in Participants With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07652372
- Acronym / sponsor ID
- LBRC_RAB001_OA / LBRC_RAB001_OA_PHI
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, RAB001, LLP2A-Alendronate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.Other government
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg | Experimental | Drug: RAB001 medium dose9 subjects and 3 receive placebo. |
| 4.5 mg | Experimental | Drug: RAB001 medium dose9 subjects and 3 receive placebo. |
| 9 mg | Experimental | Drug: RAB001 medium dose9 subjects and 3 receive placebo. |
| 18 mg | Experimental | Drug: RAB001 medium dose9 subjects and 3 receive placebo. |
| 27 mg | Experimental | Drug: RAB001 medium dose9 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (2 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAB001 medium doseTreatment 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. | Drug | 1.5 mg, 18 mg, 27 mg, 4.5 mg, 9 mg |
Primary outcome
Efficacy Endpoints-(WOMAC A1)
Time frame: Weeks 4, 8, 12, 16 and 24
Changes from baseline in the walking pain score of target knee (WOMAC A1). WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Efficacy Endpoints-WOMAC Scale A (Pain)
Time frame: Weeks 4, 8, 12, 16 and 24
Change from baseline in target knee WOMAC Scale A (Pain) score at Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints-WOMAC subscale B (stiffness)
Time frame: Weeks 4, 8, 12, 16 and 24
Change from baseline in target knee WOMAC subscale B (stiffness) score at Weeks 4, 8, 12, 16 and 24. WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Efficacy Endpoints-WOMAC subscale C (physical function)
Time frame: Weeks 4, 8, 12, 16 and 24
Change from baseline in target knee WOMAC subscale C (physical function) score at Weeks 4, 8, 12, 16 and 24. WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Efficacy Endpoints-WOMAC subscale C (physical function)
Time frame: Weeks 4, 8, 12, 16 and 24
Change from baseline in target knee total WOMAC score at Weeks 4, 8, 12, 16 and 24. WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Efficacy Endpoints
Time frame: Weeks 4, 8, 12, 16 and 24
Percentage of responders per( OMERACT-OARSI )response criteria at Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Time frame: Weeks 4, 8, 12, 16 and 24
Changes from baseline in the five KOOS subdomain scores (pain, symptoms, activities of daily living, sport and recreation function, knee-related quality of life) for the target knee at Weeks 4, 8, 12, 16 and 24. KOOS =Knee injury and Osteoarthritis Outcome Score
Efficacy Endpoints
Time frame: Weeks 4, 8, 12, 16 and 24
Changes from baseline in Patient Global Assessment (PGA) score at Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Time frame: Weeks 4, 8, 12, 16 and 24
Changes from baseline in Clinician's Global Assessment (COGA) score at Weeks 4, 8, 12, 16 and 24
Efficacy Endpoints
Time frame: Day 1 to Week 24
Cumulative intake of rescue medication (paracetamol / acetaminophen) throughout the study period.
Pharmacokinetic (PK) Endpoints Cmax
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Maximum observed plasma concentration
Pharmacokinetic (PK) Endpoints-AUC₀-ₜ
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Area under the concentration-time curve from time 0 to last measurable time point
Pharmacokinetic (PK) Endpoints-AUC₀-∞
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Area under the concentration-time curve from time 0 to infinity
Pharmacokinetic (PK) Endpoints-AUC_%Extrap
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Percentage of AUC extrapolation
Pharmacokinetic (PK) Endpoints-Tmax
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Time to reach maximum concentration
Pharmacokinetic (PK) Endpoints-t₁/₂z
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Terminal elimination half-life
Pharmacokinetic (PK) Endpoints-Vz/F
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Apparent volume of distribution (terminal phase, extravascular route)
Pharmacokinetic (PK) Endpoints-CLz/F
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Apparent total clearance (terminal phase, extravascular route)
Pharmacokinetic (PK) Endpoints-λz
Time frame: Single-dose Administration Phase: Within 1 hour prior to injection on Day 1 (0 hour), and at 5 , 10 , 15 , 30 minutes, 1 , 2 , 4 , 8 , 12 and 24 hours after injection initiation. A total of 11 blood collection time points are included.
Terminal elimination rate constant
Pharmacokinetic (PK) Endpoints-Css,max
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Steady-state maximum concentration
Pharmacokinetic (PK) Endpoints-Css,min
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Steady-state minimum concentration
Pharmacokinetic (PK) Endpoints-Css,av
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Average steady-state concentration
Pharmacokinetic (PK) Endpoints-AUC₀-τ
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Area under the curve over one dosing interval
Pharmacokinetic (PK) Endpoints-CLss/F
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Apparent total clearance at steady state
Pharmacokinetic (PK) Endpoints-Vz,ss/F
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Apparent volume of distribution at steady state
Pharmacokinetic (PK) Endpoints-Ra(Cmax)
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Accumulation ratio of maximum concentration
Pharmacokinetic (PK) Endpoints-Ra(AUC)
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Accumulation ratio of AUC
Pharmacokinetic (PK) Endpoints-DF
Time frame: Multiple-dose Administration Phase: Within 1 hour prior to injection initiation on Day 29 (0 hour), within 1 hour prior to injection initiation on Day 57 (0 hour), and at 5, 10, 15, 30 minutes, 1, 2, 4, 8, 12 and 24 hours after injection initiation.
Fluctuation degree / Degree of fluctuation
Safety Endpoints-AE(adverse events)
Time frame: Day 1 to Week 24
Safety assessments and grading of adverse events (AEs) occurring throughout the study period were performed in accordance with NCI-CTCAE Version 5.0.
Safety Endpoints-SAE(Serious adverse events)
Time frame: Day 1 to Week 24
Safety assessed by CTCAE v5.0 of the SAE(Serious adverse events) during the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Based on a comprehensive consideration of ethical compliance (informed consent), legal constraints, protection of commercial interests, and operational feasibility, individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAB001 medium dose in people with Knee Osteoarthritis, run by ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoints-(WOMAC A1) (time frame: Weeks 4, 8, 12, 16 and 24). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.