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

Last updated: December 5, 2024
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Overall Status: Completed

Phase

1

Condition

Atopic Dermatitis

Scalp Disorders

Allergies & Asthma

Treatment

VC005 Placebo

VC005

Clinical Study ID

NCT06009094
YQ-M-23-02
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

healthy subject's study:

  1. Healthy male or female subjects, aged 18-45 years (including critical values);

  2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with maleweight ≥ 50kg and female weight ≥ 45kg;

  3. All women and men with fertility potential must be willing to use at least oneefficient method of contraception from the signing of the informed consent formuntil 3 months after the last administration of the study drug, as detailed inAppendix 5;

  4. Voluntarily participate in the experiment and sign an informed consent form;

  5. Subjects who are able to communicate well with the researcher and are willing andable to comply with all planned visits, treatment plans, laboratory tests, and otherresearch procedures

patient's study:

  1. When informed consent is given, the age range is between 18 and 75 years (includingthe boundary value), regardless of gender;

  2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with maleweight ≥ 50kg and female weight ≥ 45kg;

  3. Before administration, the diagnosis of mild to moderate atopic dermatitis should bemet: Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis:total area of skin lesions 3% ≤ body surface area≤ 20%

  4. Voluntarily sign an informed consent form (with a date), indicating that the subjecthas been informed of all relevant parts of the study;

  5. All women and men with the possibility of childbirth must be willing to use at leastone efficient method of contraception from the signing of the informed consent formuntil 3 months after the last administration of the study drug, as detailed inAppendix 5;

  6. Subjects who are willing and able to comply with planned visits and treatment plans,laboratory tests, and other research procedures

Exclusion

Exclusion Criteria:

healthy subject's study:

  1. Suspected of being allergic to the study drug or any component of the study drug, orhaving an allergic constitution;

  2. Those who have received the vaccine within 2 weeks before administration or plan toreceive the vaccine during the study period;

  3. Screening for individuals who have undergone any surgery within the previous 6months;

  4. Those who participated in blood donation within the first 3 months of screening andhad a blood donation volume of ≥ 400 mL, or received blood transfusion (excludingfemale physiological blood loss);

  5. Female subjects of childbearing age had unprotected sexual intercourse with theiropposite sex partner within 14 days prior to screening;

  6. Screening of clinical trial participants (including excipient groups) who haveparticipated in any drug or medical device within the first 3 months;

  7. Pregnant and lactating women;

  8. Patients with difficulty in blood collection or inability to tolerate venouspuncture, and those with a history of needle and blood fainting;

  9. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, andcannot stop using any tobacco products from the end of screening to enrollment andduring the trial period;

  10. 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 monthsof screening, or who cannot abstain from alcohol during the trial period;

  11. Other situations where the researcher determines that it is not suitable toparticipate in the experiment.

patient's study:

  1. Suspected of being allergic to the study drug or any component of the study drug, orhaving an allergic constitution;

  2. Those who have received the vaccine within 2 weeks before administration or plan toreceive the vaccine during the study period;

  3. Screening for individuals who have undergone any surgery within the previous 6months;

  4. Those who participated in blood donation within the first 3 months of screening andhad a blood donation volume of ≥ 400 mL, or received blood transfusion (excludingfemale physiological blood loss);

  5. Screening of clinical trial participants (including excipient groups) who haveparticipated in any drug or medical device within the first 3 months;

  6. Pregnant and lactating women;

  7. Patients with difficulty in blood collection or inability to tolerate venouspuncture, and those with a history of needle and blood fainting;

  8. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, andcannot stop using any tobacco products from the end of screening to enrollment andduring the trial period;

  9. 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 monthsof screening, or who cannot abstain from alcohol during the trial period;

  10. Other situations where the researcher determines that it is not suitable toparticipate in the experiment.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: VC005 Placebo
Phase: 1
Study Start date:
July 27, 2023
Estimated Completion Date:
May 23, 2024

Connect with a study center

  • Chinese Academy of Medical Sciences Hospital of Skin Disease

    Nanjing, Jiangsu
    China

    Site Not Available

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