Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07404891
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Placebo — OTHER
    Administration Method: Intra-articular injection; the medial and lateral joint spaces are recommended as the injection sites. Total Number of Injections: 6 times
  • ALT001 — DRUG
    Administration Method: Intra-articular injection; the medial and lateral joint spaces are recommended as the injection sites. Total Number of Injections: 6 times

Study Details

This clinical trial will focus on the core efficacy endpoints including relief of pain intensity, improvement of joint motor function and enhancement of quality of life in patients. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events after medication, the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The study aims to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and provide scientific, detailed and reliable evidence-based medical data to support the optimization of clinical treatment guidelines and the formulation of individualized treatment regimens for knee osteoarthritis. Patients enrolled in the trial will receive investigational product treatment on the basis of conventional therapy. They will be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1. For each treatment course, patients in all groups will receive an injection of 2 vials of the investigational product into a single knee joint (for bilateral knee osteoarthritis, both knees may be injected, with one fixed knee joint selected for subsequent assessments). The injection will be administered once every 2 weeks for a total of 6 administrations.

Key Dates

First listed
Feb 12, 2026
Start date
Mar 18, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group
    2 vials per administration, once every 2 weeks, intra-articular injection.
  • Experimental: ALT001 Low-Dose Group
    1 vial per administration, once every 2 weeks, intra-articular injection.
  • Experimental: ALT001 High-Dose Group
    2 vials per administration, once every 2 weeks, intra-articular injection.

Primary Outcome Measure

Change in the WOMAC Pain Score of the target knee joint at 24 weeks (14 weeks after the last injection) compared with the baseline. [ Time Frame: 24 weeks (14 weeks after the last injection) ]

Central Contacts

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