Atopic DermatitisPhase 1NCT06009094
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
A Phase 1 study testing VC005 in people with Atopic Dermatitis, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- VC005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2023to 23 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subject's study:
- Healthy male or female subjects, aged 18-45 years (including critical values);
- Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
- All women and men with fertility potential must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
- Voluntarily participate in the experiment and sign an informed consent form;
- Subjects who are able to communicate well with the researcher and are willing and able to comply with all planned visits, treatment plans, laboratory tests, and other research procedures
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- patient's study:
- When informed consent is given, the age range is between 18 and 75 years (including the boundary value), regardless of gender;
- Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
- Before administration, the diagnosis of mild to moderate atopic dermatitis should be met:
- Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total area of skin lesions 3% ≤ body surface area≤ 20%
- Voluntarily sign an informed consent form (with a date), indicating that the subject has been informed of all relevant parts of the study;
- All women and men with the possibility of childbirth must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
- Subjects who are willing and able to comply with planned visits and treatment plans, laboratory tests, and other research procedures
Who cannot join
- healthy subject's study:
- Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
- Screening for individuals who have undergone any surgery within the previous 6 months;
- Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
- Female subjects of childbearing age had unprotected sexual intercourse with their opposite sex partner within 14 days prior to screening;
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- Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;
- Pregnant and lactating women;
- Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
- Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
- Other situations where the researcher determines that it is not suitable to participate in the experiment.
- patient's study:
- Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
- Screening for individuals who have undergone any surgery within the previous 6 months;
- Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
- Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;
- Pregnant and lactating women;
- Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
- Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
- Other situations where the researcher determines that it is not suitable to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Hospital of Skin Disease
Nanjing, Jiangsu
About this study
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
- Conditions
- Atopic Dermatitis
- Being tested
- VC005, VC005 Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005Drug
VC005 group with Local topical application
VC005 PlaceboDrug
VC005 Placebo group with Local topical application
| Study group | Role | What they receive |
|---|---|---|
| VC005 Low Dose groups | Experimental | Not described Receives: Drug: VC005 |
| VC005 median-A Dose groups | Experimental | Not described Receives: Drug: VC005 |
| VC005 median-B Dose groups | Experimental | Not described Receives: Drug: VC005 |
| VC005 high Dose groups | Experimental | Not described Receives: Drug: VC005 |
| VC005 Placebo groups | Placebo comparator | Not described Receives: Drug: VC005 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax）
Measured: Day2,Day 4,Day17,Day31
Secondary outcomes (1)
Changes in EASI（Eczema area and severity index） from baseline
Measured: Week 2,Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start27 Jul 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qianjin Lu, Principal investigator, Chinese Academy of Medical Sciences Hospital of Skin Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009094
- Sponsor's protocol ID
- YQ-M-23-02
- Status last verified
- Jul 2024
- First submitted
- 18 Aug 2023
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06009094
- Acronym / sponsor ID
- YQ-M-23-02
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 24 Aug 2023 (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 study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VC005 Low Dose groups | Experimental | Drug: VC005 |
| VC005 median-A Dose groups | Experimental | Drug: VC005 |
| VC005 median-B Dose groups | Experimental | Drug: VC005 |
| VC005 high Dose groups | Experimental | Drug: VC005 |
| VC005 Placebo groups | Placebo comparator | Drug: VC005 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy male or female subjects, aged 18-45 years (including critical values);
- Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
- All women and men with fertility potential must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
- Voluntarily participate in the experiment and sign an informed consent form;
- Subjects who are able to communicate well with the researcher and are willing and able to comply with all planned visits, treatment plans, laboratory tests, and other research procedures
Key exclusion criteria (23 listed)
- Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
- Screening for individuals who have undergone any surgery within the previous 6 months;
- Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
- Female subjects of childbearing age had unprotected sexual intercourse with their opposite sex partner within 14 days prior to screening;
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 |
|---|---|---|
| VC005VC005 group with Local topical application | Drug | VC005 Low Dose groups, VC005 high Dose groups, VC005 median-A Dose groups, VC005 median-B Dose groups |
| VC005 PlaceboVC005 Placebo group with Local topical application | Drug | VC005 Placebo groups |
Primary outcome
Peak Plasma Concentration (Cmax）
Time frame: Day2,Day 4,Day17,Day31
1 secondary outcome
Changes in EASI（Eczema area and severity index） from baseline
Time frame: Week 2,Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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. This study is not recruiting at the moment.
Qianjin Lu principal investigator
Chinese Academy of Medical Sciences Hospital of Skin Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VC005 in people with Atopic Dermatitis, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site 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 14 inclusion and 23 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax） (time frame: Day2,Day 4,Day17,Day31). 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 10 Dec 2024.