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Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
VC005
VC005 Placebo
Sponsored by
Jiangsu vcare pharmaceutical technology co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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; 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.

Sites / Locations

  • Chinese Academy of Medical Sciences Hospital of Skin DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

VC005 Low Dose groups

VC005 median-A Dose groups

VC005 median-B Dose groups

VC005 high Dose groups

VC005 Placebo groups

Arm Description

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Changes in EASI(Eczema area and severity index) from baseline

Full Information

First Posted
August 18, 2023
Last Updated
October 22, 2023
Sponsor
Jiangsu vcare pharmaceutical technology co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT06009094
Brief Title
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Official Title
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu vcare pharmaceutical technology co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VC005 Low Dose groups
Arm Type
Experimental
Arm Title
VC005 median-A Dose groups
Arm Type
Experimental
Arm Title
VC005 median-B Dose groups
Arm Type
Experimental
Arm Title
VC005 high Dose groups
Arm Type
Experimental
Arm Title
VC005 Placebo groups
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VC005
Intervention Description
VC005 group with Local topical application
Intervention Type
Drug
Intervention Name(s)
VC005 Placebo
Intervention Description
VC005 Placebo group with Local topical application
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Time Frame
Day2,Day 4,Day17,Day31
Secondary Outcome Measure Information:
Title
Changes in EASI(Eczema area and severity index) from baseline
Time Frame
Week 2,Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojuan Lai
Phone
15358160458
Email
lai_xiaojuan@vcarepharmatech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianjin Lu
Organizational Affiliation
Chinese Academy of Medical Sciences Hospital of Skin Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Hospital of Skin Disease
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianjin Lu
Phone
13787097676
Email
qianlu5860@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis

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