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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07731685

Enrollment

Registered

2026-07-28

Start date

2026-07-30

Completion date

2027-12-30

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in Bone Metastases

Brief summary

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

Interventions

DRUGVC004 low dose

VC004 low dose BID

DRUGVC004 high dose

VC004 high dose BID

DRUGVC004 placebo

VC004 placebo BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score	At Week 1, Week 2 and Week 4

Countries

China

Contacts

CONTACTxiaojuan lai

lai_xiaojuan@vcarepharmatech.com+8615358160458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026