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

NCT06009094 | Completed Phase 1

• 1 other identifier: YQ-M-23-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax）

  Day2,Day 4,Day17,Day31

Secondary Outcomes (1)

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

  Week 2,Week 4

Study Arms (5)

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

Interventions

VC005 DRUG

VC005 group with Local topical application

VC005 Low Dose groups; VC005 high Dose groups; VC005 median-A Dose groups; VC005 median-B Dose groups

VC005 Placebo DRUG

VC005 Placebo group with Local topical application

VC005 Placebo groups

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Chinese Academy of Medical Sciences Hospital of Skin Disease

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qianjin Lu

  Chinese Academy of Medical Sciences Hospital of Skin Disease

  PRINCIPAL INVESTIGATOR

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: August 18, 2023
• First Posted: August 24, 2023
• Study Start: July 27, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-07

Locations

CN (1)