Pain in Bone MetastasesPhase 1NCT07731685
A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases
A Phase 1 study testing VC004 low dose and VC004 high dose in people with Pain in Bone Metastases, run by Jiangsu vcare pharmaceutical technology co., LTD at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain in Bone Metastases
- What is being tested?
- VC004 low dose and VC004 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jul 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Zhongda Hospital,Affiliated to Southeast University
Nanjing, Jiangsu
Lin Liu, 13913968688, wenyu811@126.com
Zhongda Hospital,Affiliated to Southeast University
Nanjing, Jiangsu
About this study
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
- Being tested
- VC004 low dose, VC004 high dose, VC004 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC004 low doseDrug
VC004 low dose BID
VC004 high doseDrug
VC004 high dose BID
VC004 placeboDrug
VC004 placebo BID
| Study group | Role | What they receive |
|---|---|---|
| VC004 low dose group | Experimental | Not described Receives: Drug: VC004 low dose |
| VC004 high dose group | Experimental | Not described Receives: Drug: VC004 high dose |
| VC004 placebo group | Placebo comparator | Not described Receives: Drug: VC004 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
Measured: At Week 1, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731685
- Sponsor's protocol ID
- VC004-104
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases
- ClinicalTrials.gov ID
- NCT07731685
- Acronym / sponsor ID
- VC004-104
- Conditions
- Pain in Bone Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC004 low doseVC004 low dose BID | Drug | VC004 low dose group |
| VC004 high doseVC004 high dose BID | Drug | VC004 high dose group |
| VC004 placeboVC004 placebo BID | Drug | VC004 placebo group |
Primary outcome
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
Time frame: At Week 1, Week 2 and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VC004 low dose and VC004 high dose in people with Pain in Bone Metastases, run by Jiangsu vcare pharmaceutical technology co., LTD at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaojuan lai (+8615358160458, lai_xiaojuan@vcarepharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score (time frame: At Week 1, Week 2 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.