NCT07404891

Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

Single-Center, Randomized, Double-Blind, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of ALT001 for Osteoarthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled after signing the informed consent form and meeting the inclusion/exclusion criteria, with a planned enrollment of 30 participants. All enrolled patients will receive the study drug on the basis of conventional treatment, and be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1 (see Table 1 for details). Patients in each group will receive an injection of 2 vials of the study product into a single knee joint per treatment session (for bilateral osteoarthritis, both knees may be injected, while a fixed knee joint will be selected for subsequent assessments). Injections will be administered once every 2 weeks for a total of 6 times. Follow-up assessments will be conducted concomitantly with injections at 2, 4, 6, 8 and 10 weeks after the first injection, and all safety and efficacy data will be collected during these visits. The entire study consists of the following phases: Screening Period (Day -7 to Day 0), Treatment Visit 1 (first injection, Day 0), Treatment Visit 2 (second injection, Week 2 ±3 days), Treatment Visit 3 (third injection, Week 4 ±3 days), Treatment Visit 4 (fourth injection, Week 6 ±3 days), Treatment Visit 5 (fifth injection, Week 8 ±3 days), Treatment Visit 6 (sixth injection, Week 10 ±3 days), Follow-up Visit 7 (Week 12 ±5 days), Follow-up Visit 8 (Week 18 ±7 days) and Follow-up Visit 9 (Week 24 ±7 days). The outcome measures of this clinical trial are based on the participants' subjective evaluations. To avoid bias in trial results caused by participants' subjective perceptions, a blinded design is applied to all participants. A double-blind design is also adopted, with follow-up investigators masked, to prevent the investigators' subjective judgments from influencing participants during follow-up. This trial uses a placebo-controlled design, where the trial conditions, clinical observation items and evaluation criteria are consistent between the experimental and control groups. In addition, participants in the two groups are assigned in accordance with the randomization principle. This clinical trial is developed in response to the urgent clinical need for safe and effective interventions in the treatment of knee osteoarthritis. In accordance with the principles of evidence-based medicine, a rigorous controlled study protocol has been designed. Through standardized trial procedures and a unified evaluation system, this trial will systematically and comprehensively assess the clinical application value of ALT001, manufactured by Darwin Starting Point (Hubei) Biopharmaceutical Co., Ltd., in patients with knee osteoarthritis. The study will focus on core efficacy endpoints including the degree of pain relief, improvement in joint motor function and enhancement of quality of life in patients. Meanwhile, key safety indicators such as the incidence of various adverse events after administration, the severity and duration of adverse reactions will be closely monitored. A multi-dimensional and multi-level comprehensive assessment will be conducted to clarify the clinical benefit characteristics and safety risks of the study product ALT001, thereby providing scientific, detailed and reliable evidence-based medical data to optimize clinical treatment guidelines and formulate individualized treatment regimens for knee osteoarthritis. This clinical trial is conducted in response to the urgent clinical need for safe and effective interventions in the treatment of knee osteoarthritis. In accordance with the principles of evidence-based medicine, a rigorous controlled study protocol has been designed. Through standardized trial procedures and a unified evaluation system, this study will systematically and comprehensively assess the clinical efficacy of ALT001, manufactured by Darwin Starting Point (Hubei) Biopharmaceutical Co., Ltd., in patients with knee osteoarthritis. The trial will focus on core efficacy endpoints including the relief of pain intensity, improvement of joint motor function and enhancement of patients' quality of life. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events following medication administration, as well as the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The aim is to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and to 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.

Conditions

• Osteoarthritis

Interventions

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

Timeline

• Start date: 2026-03-18
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2026-02-12
• Last updated: 2026-03-24

Locations

1 site across 1 country: China