A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases

This is a randomized, double-blind, placebo-controlled Phase Ib study evaluating the safety and efficacy of VC004 capsules for the relief of moderate-to-severe pain associated with bone metastases

Inclusion Criteria: 1. Participants must understand and voluntarily sign the informed consent form (ICF); 2. Male or female, aged ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4. Life expectancy of ≥ 12 weeks, as assessed by the investigator; 5. The participant is able to communicate well with the investigator, and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. The participant's pain is associated with oncologic emergencies, such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture or impending fracture of weight-bearing bones; 2. The participant has known or suspected unstable brain metastases or leptomeningeal metastases； 3. History of severe alcohol, analgesic, or narcotic drug abuse within 6 months prior to screening; 4. Major surgery within 3 months prior to screening, or planned major surgery during the study period; 5. Female participants who are planning to become pregnant, are pregnant, or are breastfeeding; or participants who are unwilling or unable to use effective contraception throughout the entire study period and for 3 months after the end of the study; 6. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.