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

NCT07731685 | Not Yet Recruiting Phase 1

• 1 other identifier: VC004-104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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

Conditions

Pain in Bone Metastases

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score

  At Week 1, Week 2 and Week 4

Study Arms (3)

VC004 low dose group

EXPERIMENTAL

Drug: VC004 low dose

VC004 high dose group

EXPERIMENTAL

Drug: VC004 high dose

VC004 placebo group

PLACEBO COMPARATOR

Drug: VC004 placebo

Interventions

VC004 low dose DRUG

VC004 low dose BID

VC004 low dose group

VC004 high dose DRUG

VC004 high dose BID

VC004 high dose group

VC004 placebo DRUG

VC004 placebo BID

VC004 placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must understand and voluntarily sign the informed consent form (ICF);
• Male or female, aged ≥ 18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• Life expectancy of ≥ 12 weeks, as assessed by the investigator;
• 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.

You may not qualify if:

• 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;
• The participant has known or suspected unstable brain metastases or leptomeningeal metastases；
• History of severe alcohol, analgesic, or narcotic drug abuse within 6 months prior to screening;
• Major surgery within 3 months prior to screening, or planned major surgery during the study period;
• 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;
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (2)

Zhongda Hospital,Affiliated to Southeast University

Nanjing, Jiangsu, China

Location

Zhongda Hospital,Affiliated to Southeast University

Nanjing, Jiangsu, China

Location

Central Study Contacts

xiaojuan lai

CONTACT

+8615358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (2)